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Trial registered on ANZCTR


Registration number
ACTRN12611000129987
Ethics application status
Approved
Date submitted
1/02/2011
Date registered
4/02/2011
Date last updated
4/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intra-examiner reproducibility of probing pocket depth using four types of manual periodontal probes, in vivo
Scientific title
Intra-examiner reproducibility of probing pocket depth with four manual probes types in healthy volunteers.
Secondary ID [1] 253520 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diagnosis of periodontal disease 261069 0
Condition category
Condition code
Oral and Gastrointestinal 259215 259215 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
Periodontal probing depth with four types of manual probes in healthy volunteers
One trained examiner will measure PD in 20 patients to determine the intra-examiner reproducibility with four types of manual periodontal probes in two times measurements by each patient and each probe (Baseline and repeated measurement) as follows: FIRST DAY: PD on Patient 1 (Baseline), SECOND DAY: PD on Patient 2 (Baseline), THIRD DAY: PD on Patient 3 (Baseline), FOURTH DAY: PD on Patient 4 (Baseline), FIFTH DAY: PD on Patient 5 (Baseline) and Patient 1 (repeated probing), SIXTH DAY: PD on Patient 6 (Baseline) and Patient 2 (repeated probing), SEVENTH DAY: PD on Patient 7 (Baseline) and Patient 3 (repeated probing), EIGHTH DAY: PD on Patient 8 (Baseline) and Patient 4 (repeated probing), the sequence will continue at the same manner until reach the patient number 20. PD is defined as the measurement in millimeters from the gingival margin to the bottom of the gingival sulcus. The study will use a Williams manual periodontal probe (1, 2, 3, 5, 7, 8, 9 and 10 mm Hu-Friedy), Colorvue periodontal probe (3, 6, 9 and 12mm Hu-Friedy); PDT Sensor Probe 2M-12 (2, 4, 6, 8, 10 and 12mm Pro-Dentec, Batesville AR), and UNC 15/23 manual probe (1 to 15mm Paradise Dental Technologies). The examiner will introduce each probe in the interior of the gingival sulcus and following the length of the tooth until resistance will be felt by the penetrating probe. Each patient will have six sites probed per tooth (mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual), excluding third molars. The PD measurements will do using the following criteria: all measurements will be round to the closest 0.5 mm (up or down), when the PD measurements are exactly between two marks on the probe the closest millimeter immediately above the mark will recorded. Each patient will have a minimum of six teeth per quadrant in order to be included in the study. The perfect squares formula will be used to random distribution of probes and areas to will be probed.
Intervention code [1] 257945 0
Diagnosis / Prognosis
Intervention code [2] 257946 0
Early detection / Screening
Comparator / control treatment
Intra-examiner reproducibility by duplicated measurements of probing pocket depth with four types of manual periodontal probes on healthy patients
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262053 0
Primary Outcome 1:
Assess the inter-examiner reproducibility on clinical register of probing pocket depth in healthy patients (without periodontal disease) using different measurement tools (four types of manual periodontal probes).
Timepoint [1] 262053 0
During a period of three months, the examiner selected subjects who will participate in the study based on exclusion and inclusion criterions (participants selection). From June to August 2008.
After subjects selection, during a period of 6 months, the examiner worked on calibration process until demonstrate that he was calibrated (in subjects that were not part of the experimental group) according to parameters: Substantial kappa values, 90% measurements agreement not bigger or smaller than 1mm and an exact agreement in 75% of the PD repeated measurements. From September 2008 to February 2009.
Once the examiner demonstrates that has been trained within the abovementioned parameters, the study will be initiated. Finally, 6 months to collect and assess the datas.
Secondary outcome [1] 273038 0
Assess the reproducibility differences between the Probing depth with four types of manual periodontal probes on mesial tooth surfaces vs. distal tooth surfaces
Timepoint [1] 273038 0
Timepoint: 6 months.
Secondary outcome [2] 273039 0
Assess the reproducibility differences between the Probing depth with four types of manual periodontal probes on anterior vs. posterior mouth areas.
Timepoint [2] 273039 0
Timepoint: 6 months.
Secondary outcome [3] 273040 0
Assess the reproducibility differences between the Probing depth with four types of manual periodontal probes on buccal vs. lingual tooth surfaces.
Timepoint [3] 273040 0
Timepoint: 6 months.
Secondary outcome [4] 273041 0
Assess the reproducibility differences between the Probing depth with four types of manual periodontal probes on superior vs. inferior dental arch.
Timepoint [4] 273041 0
Timepoint: 6 months.

Eligibility
Key inclusion criteria
Healthy patients: No signs of periodontal destructive disease (loss of clinical attachment).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who have received treatments of fixed or partial prosthetics, individual crowns or orthodontia; surgical or non-surgical periodontal treatments in the last eight months; been taking antibiotics; or be pregnant

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3164 0
El Salvador
State/province [1] 3164 0
San Salvador

Funding & Sponsors
Funding source category [1] 258410 0
Self funded/Unfunded
Name [1] 258410 0
None
Country [1] 258410 0
Primary sponsor type
Individual
Name
Roberto Antonio Andrade Acevedo
Address
Centro de Salud Integral, 5 calle poniente 4212, colonia Escalon, San Salvador, El Salvador, Central America
Country
El Salvador
Secondary sponsor category [1] 257561 0
None
Name [1] 257561 0
None
Address [1] 257561 0
None
Country [1] 257561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260384 0
CIE. Institutional Ethics Comite of Evangelic University of El Salvador. UEES.
Ethics committee address [1] 260384 0
Universidad Evangelica de El Salvador. First Building, Third floor. Prolongacion Alameda Juan Pablo II, Calle El Carmen, San Salvador, El Salvador, Central America.
Ethics committee country [1] 260384 0
El Salvador
Date submitted for ethics approval [1] 260384 0
Approval date [1] 260384 0
Ethics approval number [1] 260384 0
Certificate assessment of clinical study n0 9

Summary
Brief summary
The periodontal probe remains as the best clinical diagnostic tool to collect information regarding the health status and the attachment level of periodontal tissues. The aim of the present study is to evaluate the intra-examiner reproducibility of probing pocket depth (PPD) measurements with a four types of manual periodontal probes. Methods: Previously accepted by an Ethical Committee and after informed consent, 20 subjects without periodontal disease were selected if they presented at least 6 teeth per quadrant without antibiotic therapy in the last 8 months. One calibrated examiner (k>0.6), will assess PPD from all teeth at 6 sites/tooth with Williams (1, 2, 3, 5, 7, 8, 9 and 10 mm), Colorvue (3, 6, 9 and 12mm); PDT Sensor Probe 2M-12 (2, 4, 6, 8, 10 and 12mm), and UNC 15/23 (1 to 15mm) manual periodontal probes from the gingival margin to the bottom of the periodontal sulcus (rounded to the next 0.5mm). Initial (Baseline) and repeated measurements will performed by one trained examiner.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32154 0
Address 32154 0
Country 32154 0
Phone 32154 0
Fax 32154 0
Email 32154 0
Contact person for public queries
Name 15401 0
Roberto Antonio Andrade Acevedo. Titular Professor in Periodontics. Evangelic University of El Salvador. San Salvador, El Salvador, Central America.
Address 15401 0
Centro de Salud Integral 4212. Colonia Escalon, San Salvador, Central America.
Country 15401 0
El Salvador
Phone 15401 0
+(503) 2264 6321 (for San Salvador, El Salvador, Central America)
Fax 15401 0
Email 15401 0
[email protected], [email protected], [email protected].
Contact person for scientific queries
Name 6329 0
Roberto Antonio Andrade Acevedo. Titular Professor in Periodontics. Evangelic University of El Salvador. San Salvador, El Salvador, Central America.
Address 6329 0
Centro de Salud Integral 4212. Colonia Escalon, San Salvador, Central America.
Country 6329 0
El Salvador
Phone 6329 0
+(503) 2264 6321 (for San Salvador, El Salvador, Central America)
Fax 6329 0
Email 6329 0
[email protected], [email protected], [email protected].

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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