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Trial registered on ANZCTR

Registration number

ACTRN12621001350819

Ethics application status

Approved

Date submitted

22/04/2021

Date registered

7/10/2021

Date last updated

7/10/2021

Date data sharing statement initially provided

7/10/2021

Date results information initially provided

7/10/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Efficacy of Modified Piezocision Corticotomy Procedure to Accelerate Orthodontic Tooth Movement

Scientific title

The Efficacy of Modified Flapless Corticotomy Using Piezocision Procedure to Accelerate Orthodontic Tooth Movement in Premolar Extraction Cases

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Adult patients with severe maxillary and mandibular incisor crowding

Patient with crowding malocclusion on both jaw required all first premolar tooth extraction for orthodontic treatment purpose

7-9mm incisor crowding based on Little’s Irregularity Index.

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Seven to ten days after first premolar extraction, experimental group received fixed orthodontic appliances of the pre-adjusted edgewise McLaughlin Bennett Trevisi (MBT) prescription brackets and buccal tube of the 0.022-inch slot (Natural orthodontic product) were bonded from the first molar to the first molar teeth, with light cure bonding kit, i.e., Transbond XT (3M Unitek, Monrovia, Calif), and curing was performed by using a light-emitting diode (Dentsply International, York, Pa). To initiate the levelling and alignment phase a first archwire 0.012-inch nickel-titanium (3M Unitek) was inserted and tied to each bracket in the maxillary and mandibular arch using an elastic module just immediate after the bonding of each brackets completed. After that, the archwire sequences were maintained 0.016-inch, 0.017 × 0.025–inch, and 0.019 × 0.025–inch nickel-titanium used for ideal alignment. The approximate amount of time taken to bond the fixed orthodontic appliance and placement of first archwire together was 20-25 minutes. The follow up visit to activate the orthodontic appliance was performed every 4-5 weeks until complete the leveling and alignment. Each number of archwires was replaced only when the possibility for full engagement into the brackets slot with a minimal amount of bending and without expressing excessive force on anterior teeth. Hence, it could produce an adequate amount of force for the tooth movement and achieved ideal leveling and alignment. There was also used lace back ligature from the first molar to second premolar tooth to prevent the anchorage loss and proclination of the anterior tooth. During each appointment, the position of all the brackets was evaluated, and if required, the bracket was re-bonded to the correct position to achieve the ideal alignment. The completion of leveling and alignment of the teeth was considered finished when Little’s Irregularity Index (LII) of the anterior teeth show 0 mm, and the feasibility of inserting the final archwire 0.019 x 0.025 SS passively into all brackets as the bracket slot used 022-inch.

Experimental subjects received piezocision corticotomy procedure 5-10 minutes after the bonding of fixed orthodontic appliances on same day. Before surgery proper aseptic technique was maintained, all instrument used for this surgery purpose was sterilized by autoclave, and before start surgery patient was advised to rinse the mouth with 0.2% chlorhexidine mouth wash. A panoramic radiograph was used to assess the root proximity and the long axis of the teeth before starting the procedure. Local anaesthesia was administered using 2 percent Lidocaine with 1:100000 epinephrine. After given local anaesthesia, seven vertical interproximal incisions were made by using a 15C surgical scalpel blade through the gingiva on the labial aspect of the maxillary and mandibular six anterior teeth. In cases of root proximity, this procedure was not performed in that particular area.

The scalpel blade was positioned on the inter radicular attached gingiva at an inclination of 45– 60 degree to the long axis of the maxillary and mandibular six anterior teeth. The vertical incisions were made 3mm below from the interdental papilla to preserve the papillary gingival margin and to preserve the alveolar crest, and extended the incision line up to 4-5mm long. Once the incisions were made, the gingiva was slightly elevated laterally to check out the bone and roots. A piezosurgical blade (BS1 insert, Satelec Acteon Group) was inclined at 45– 60 degree to the long axis of the tooth to perform the cortical alveolar incisions 3mm below from the alveolar crest at a depth of 3mm to reach the medullary bone. The depth of piezotome cutting was measured by millimeter marking on the blade itself and maintained the cutting depth continuously during the operation. The piezoelectric device setting was adjusted to deliver low-frequency ultrasonic waves (28–36 kHz) with the power button one that is required for cutting the cortical bone, including continuous irrigation of 60% saline. Under these conditions, the micro-vibrations that are creating in the piezoelectric hand piece cause the inserts to vibrate linearly between 30 and 60µm; also used high-speed suction to remove any excess fluid. After surgery, no subsequent sutures were required as it is a minor surgery, and no bone grafts were required. Hemostasis was maintained by cotton gauze and thumb pressure. The patients were advised to take analgesics (paracetamol) only if necessary and careful tooth brushing and use 0.2% chlorhexidine mouthwash twice a day for one week were recommended. All experimental subjects were advised to contact immediately to the Orthodontic Clinic of HUSM if any complications arise after surgery and get ensure normal healing.

The approximate time taken to complete the piezocision corticotomy procedure was 30-40 minutes. All the piezocision procedure and orthodontic procedure was performed by the principal investigator who is a Orthodontist.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Seven to ten days after first premolar extraction, control group received fixed orthodontic appliances of the pre-adjusted edgewise McLaughlin Bennett Trevisi (MBT) prescription brackets and buccal tube (Natural orthodontic product) of the 0.022-inch slot were bonded from the first molar to the first molar, with light cure bonding kit, i.e., Transbond XT. (3M Unitek, Monrovia, Calif) and curing was performed by using a light-emitting diode (Dentsply International, York, Pa).

To initiate the leveling and alignment phase of orthodontic treatment of both groups, a 0.012-inch nickel-titanium archwire (3M Unitek) was inserted and tied to each bracket in the maxillary and mandibular arch using an elastic module. After that, the archwire sequences were 0.016-inch, 0.017 × 0.025–inch, and 0.019 × 0.025–inch nickel-titanium used for ideal alignment. The approximate amount of time taken to bond the fixed orthodontic appliances and placement of first archwire together was 20-25 minutes. Each number of archwires were replaced only when the possibility for full engagement into the brackets slot with a minimal amount of bending and without expressing excessive force on anterior teeth. Hence, it could produce an adequate amount of force for the tooth movement and achieved ideal leveling and alignment. There was also used lace back ligature from the first molar to second premolar tooth to prevent the anchorage loss and proclination of the anterior tooth. Finally, 0.019 x 0.025-inch stainless steel (SS) archwire was placed after completion of the leveling and alignment stage of orthodontic treatment as the bracket slot used 022-inch.

Patients were evaluated every 4-5 weeks after first archwire placement. During each appointment, the position of all the brackets was evaluated, and if required, the bracket was re-bonded to the correct position to achieve the ideal alignment. The completion of leveling and alignment of the teeth was considered finished when Little’s Irregularity Index (LII) of the anterior teeth show 0 mm, and the feasibility of inserting the final archwire 0.019 x 0.025 SS passively into all brackets. The orthodontic procedure for every patient was carried out by the principal investigator who is an Orthodontist.

Control group

Active

Outcomes

Primary outcome [1]

Determine and compare the time duration needed to complete the leveling and alignment of maxillary and mandibular anterior teeth (canine to canine) in the modified piezocision and conventional orthodontics group. To measure the primary outcome study cast impression was taken from both maxilla and mandibular arch and from each patient at baseline (T0) and end of leveling and alignment (T3). Little's Irregularities Index (LII) was used to measure the tooth movement (in mm) at baseline and consider the complete leveling and alignment when LII become 0 mm (T3). We calculate the overall treatment time by the number of days between the T0 and T3 time points.

Timepoint [1]

At baseline (T0) and end of leveling and alignment (T3), monthly

Secondary outcome [1]

Assess and compare the changes of gingival recession at baseline (T0) and end of leveling and alignment (T3) of maxillary and mandibular teeth in piezocision and conventional orthodontics group. Gingival recession was measured on 1st molar to 1st molar teeth of both jaw by using Who periodontal probe. Gingival recession was measured as the distance from the cementoenamel junction to the free gingival margin. The mean gingival recession and pocket depth was calculated by subtracting the score obtained at T0 from the T3.

Timepoint [1]

At baseline (T0) and end of leveling and alignment (T3) monthly

Secondary outcome [2]

Assess the patient perception about pain level score about the surgical procedure in the experimental group. The experimental group completed a self-administered questionnaire based on numeric rating scale, that assessed the perception of pain score with the procedure at the end of surgery and collected one week later. The patients were asked whether they felt any pain after the surgery and to rate the score using a unidimensional measure that ranges from 0-10, which is then categorized as no pain (0), mild pain (1-3), moderate pain (4-6), severe pain (7-10).

Timepoint [2]

1 week later of piezocision surgery procedure

Secondary outcome [3]

Assess and compare the changes of pocket depth at baseline (T0) and end of leveling and alignment (T3) of maxillary and mandibular teeth in piezocision and conventional orthodontics group. Pocket depth was measured on 1st molar to 1st molar teeth of both jaw by using Who periodontal probe. Pocket depth was recorded at 3 points only mesiobuccal, mid-buccal, and distobuccal. The mean pocket depth was calculated by subtracting the score obtained at T0 from the T3.

Timepoint [3]

At baseline (T0) and end of leveling and alignment (T3) monthly.

Secondary outcome [4]

Assess and compare the changes of pulp vitality at baseline (T0) and end of leveling and alignment (T3) of maxillary and mandibular teeth in piezocision and conventional orthodontics group. An electric pulp tester (EPT) was used to assess the pulp/tooth vitality on first molar to first molar tooth of both jaw and both group. The electric pulp tester readings were recorded, as positive or negative (yes or no) responses

Timepoint [4]

At Baseline (T0) and end of leveling and alignment (T3) monthly.

Secondary outcome [5]

Assess the patient perception of satisfaction score about the surgical procedure in the experimental group. The experimental group completed a self-administered questionnaire based on numeric rating scale, that assessed the perception of satisfaction score about the procedure at the end of surgery and collected one week later. The patients were asked to put the satisfaction score about the surgical procedure using the numeric rating scale and the score was categorized as extremely unsatisfied (0), unsatisfied ((1-2), neutral (3-5), satisfied (6-8), extremely satisfied (9-10).

Timepoint [5]

1 week later of piezocision surgery.

Eligibility

Key inclusion criteria

1. Clinically healthy patient, no systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, vitamin D deficiency or bony lesion.
2. Age range between 18-30 years.
3. Patients with severe maxillary and mandibular incisors irregularity according to Little’s Irregularity Index 7-9mm indicating extraction of two first premolars in both jaw.
4. The feasibility of bonding brackets and engage the initial archwire on all maxillary and mandibular teeth on the same day.
5. The subject had vital teeth with periodontium probing depth values not exceeding 3 mm across the entire dentition and attachment loss up to 2 mm.

Minimum age

18 Years

Maximum age

30 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Uncontrolled diabetics mellitus, reporting the use of NSAID’s, Bisphosphonates or corticosteroid medications throughout the study.
2. Patient with a history of previous orthodontic treatment.
3. Missing or impacted permanent teeth except for the third molar.
4. Radiographic evidence of root resorption.
5. Cleft lip or palate and other syndromes or craniofacial deformities.
6. Severe Increased or decreased maxilla mandibular plane angle (MMPA) and Frankfurt mandibular plane angle (FMPA).
7. Patient with anterior open bite, deep bite and buccally erupted canine teeth.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation concealment was done by sealed enelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomization was performed by preparing 16 sealed and unnumbered envelopes containing a piece of paper printed with the word ‘Piezocision’ or ‘Conventional’. Each consented patient was asked to select one envelope and opened it in front of the researcher for the record. This approach prevents selection bias in this unblinded trial and randomly assigns the patients with an allotted ratio of 1:1 to the treatment groups.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The data were statistically analyzed using SPSS version 26 (Chicago, USA). Simple descriptive statistics were used to summarize and examine the data distribution, including questionnaire survey data. After performing the normal distribution test of the outcome variables, parametric tests were performed on the parameters having a normal distribution, while non-parametric tests were performed on the parameters with non-normal distributions. The Shapiro-Wilk test was performed to test the data for normal distribution. The Mann-Whitney U-test was used to assess the non-parametric variables. Characteristics between control and experimental groups were examined by independent sample t-tests and chi-square test. An Independent t-test was applied to evaluate and compare the mean changes of variables from baseline to end of treatment in between groups. One-way repeated measure analysis of variance (ANOVA) and Post hoc LSD test was applied to evaluate the mean alignment rate changes between time and group. The results were considered significant at the 95% confidence interval (P<0.05).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

22/10/2018

Date of last participant enrolment

Anticipated

Actual

3/01/2020

Date of last data collection

Anticipated

Actual

9/03/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Kelantan

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Hospital Universiti Sains Malaysia

Address [1]

Jabatan Pembangunan Kampus Kesihatan USM. Jalan Raja Perempuan Zainab 2. Kubang Kerian 16150 Kota Bharu Kelantan.

Country [1]

Malaysia

Primary sponsor type

Hospital

Name

Hospital Universiti Sains Malaysia

Address

Jabatan Pembangunan Kampus Kesihatan USM. Jalan Raja Perempuan Zainab 2. Kubang Kerian 16150 Kota Bharu Kelantan.

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Jawatankuasa Etika Penyelidikan Manusia, Universiti Sains Malaysia (JEPeM-USM)

Ethics committee address [1]

Human Research Ethics Committee Division of Research and Innovation (R&I), Health Campus, Universiti Sins Malaysia, 16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia.

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

15/11/2017

Approval date [1]

05/04/2018

Ethics approval number [1]

USM/JEPeM/17110591

Summary

Brief summary

The trial design consisted of two groups, the control and the piezocision (experimental) group. The experimental group receive piezocision surgery performed by piezotome device with an adjustment of low-frequency waves (28-36kHz).

The purpose of this study was to investigate the efficacy of the piezocision procedure to accelerate tooth movement during leveling and alignment phase of orthodontic treatment.

This study hypothesized that the piezocision procedure could accelerate the tooth movement thereby reduce the treatment time of levelling and alignment stage than control group.

Trial website

Trial related presentations / publications

Public notes

This is a randomized clinical trial study having the primary objective of investigating the efficacy of the piezocision flapless corticotomy procedure to accelerate leveling and alignment in orthodontic treatment that required premolar extraction. Besides that, this study has also investigated the influence of piezocision surgical approach on surrounding tooth structure such as gingival recession, periodontal pocket depth, tooth vitality, and changes of Little’s Irregularity Index. This study was also being investigated pain level and level of satisfaction score among patients who underwent piezocision procedure.

The trial design consisted of two groups, the control and the piezocision (experimental) group. This clinical trial recruited 16 patients who had severe anterior crowding about 7-9mm based on Little’s Irregularity Index of both maxilla and the mandible; each group had an equal number of eight patients chosen randomly. The control group receive only conventional fixed orthodontics treatment. The experimental group receive piezocision surgery with conventional fixed orthodontics treatment. The piezotome device was used to perform the less invasive flapless corticotomy with an adjustment of low-frequency waves (28-36kHz). The modified piezocision procedure includes 4-5 mm long incision with 3 mm depth of alveolar bone corticotomies. Follow up visit to activate the orthodontic appliances was every 4-5 weeks.

Maxilla and mandibular study cast were taken at a baseline (T0), at one month (T1), at
two month (T2) and end of leveling and alignment (T3) to assess the overall alignment time, changes in the LII, and alignment rate. The periodontal parameters (gingival recession and pocket depth) and pulp vitality test were evaluated at T0 and T3 time point. Patient perception of the pain level and level of satisfaction with a numeric rating scale was assessed following the piezocision procedure.

A total of 16 patients were recruited in this study, however, 13 patients (7 control and 6 piezocision) in the maxilla completed the study, whereas, in the mandible, a total of 10 patients (7 control and 3 piezocision) completed the study. The reason of attrition of patient due to lost of follow-up visit because of the movement control order from Malaysian Government due to COVID-19 pandemic.

This study could help both patient and orthodontist to reduce hustle from the busy schedule of their daily life, especially patient who lives far from the clinic place. As a result, it will reduce burnout patient from orthodontic treatment. Also the orthodontists can treat more number of patients within a short period of time thereby reducing the number of waiting list

Contacts

Principal investigator

Name

Dr Sharmin Sultana

Address

PhD Student, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia

Country

Malaysia

Phone

+60146090992

Fax

[email protected]

Contact person for public queries

Name

Dr Sharmin Sultana

Address

PhD Student, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia

Country

Malaysia

Phone

+60146090992

Fax

[email protected]

Contact person for scientific queries

Name

Dr Norma Ab Rahman

Address

Unit of Orthodontics, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia

Country

Malaysia

Phone

+60199818248

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

For confidentiality issues and participants consent

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11446	Ethical approval					381838-(Uploaded-22-04-2021-04-38-34)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of piezocision procedure in levelling and alignment stage of fixed orthodontic treatment: a randomized clinical trial.	2022	https://dx.doi.org/10.1038/s41598-022-09851-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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