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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
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] 304005 0
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 321623 0
Patient with crowding malocclusion on both jaw required all first premolar tooth extraction for orthodontic treatment purpose 321625 0
7-9mm incisor crowding based on Little’s Irregularity Index. 322935 0
Condition category
Condition code
Oral and Gastrointestinal 319366 319366 0 0
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] 320315 0
Treatment: Surgery
Intervention code [2] 321229 0
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] 327239 0
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] 327239 0
At baseline (T0) and end of leveling and alignment (T3), monthly
Secondary outcome [1] 394343 0
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] 394343 0
At baseline (T0) and end of leveling and alignment (T3) monthly
Secondary outcome [2] 394344 0
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] 394344 0
1 week later of piezocision surgery procedure
Secondary outcome [3] 398661 0
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] 398661 0
At baseline (T0) and end of leveling and alignment (T3) monthly.
Secondary outcome [4] 398662 0
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] 398662 0
At Baseline (T0) and end of leveling and alignment (T3) monthly.
Secondary outcome [5] 398663 0
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] 398663 0
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?
No
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 23616 0
Malaysia
State/province [1] 23616 0
Kelantan

Funding & Sponsors
Funding source category [1] 308386 0
Hospital
Name [1] 308386 0
Hospital Universiti Sains Malaysia
Country [1] 308386 0
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] 309215 0
None
Name [1] 309215 0
Address [1] 309215 0
Country [1] 309215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308351 0
Jawatankuasa Etika Penyelidikan Manusia, Universiti Sains Malaysia (JEPeM-USM)
Ethics committee address [1] 308351 0
Ethics committee country [1] 308351 0
Malaysia
Date submitted for ethics approval [1] 308351 0
15/11/2017
Approval date [1] 308351 0
05/04/2018
Ethics approval number [1] 308351 0
USM/JEPeM/17110591

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110410 0
Dr Sharmin Sultana
Address 110410 0
PhD Student, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia
Country 110410 0
Malaysia
Phone 110410 0
+60146090992
Fax 110410 0
Email 110410 0
Contact person for public queries
Name 110411 0
Sharmin Sultana
Address 110411 0
PhD Student, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia
Country 110411 0
Malaysia
Phone 110411 0
+60146090992
Fax 110411 0
Email 110411 0
Contact person for scientific queries
Name 110412 0
Norma Ab Rahman
Address 110412 0
Unit of Orthodontics, School of Dental Sciences, Health Campus, Universiti Sains Malaysia, 16150, Kota Bharu, Kelantan, Malaysia
Country 110412 0
Malaysia
Phone 110412 0
+60199818248
Fax 110412 0
Email 110412 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality issues and participants consent


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11446Ethical approval    381838-(Uploaded-22-04-2021-04-38-34)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of piezocision procedure in levelling and alignment stage of fixed orthodontic treatment: a randomized clinical trial.2022https://dx.doi.org/10.1038/s41598-022-09851-0
N.B. These documents automatically identified may not have been verified by the study sponsor.