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Trial registered on ANZCTR


Registration number
ACTRN12611000044921
Ethics application status
Approved
Date submitted
6/01/2011
Date registered
13/01/2011
Date last updated
13/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intra and inter-examiner reproducibility of probing pocket depth in vivo
Scientific title
"Intra and inter-examiner reproducibility of probing pocket depth with a manual probe in healthy volunteers".
Secondary ID [1] 253328 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention and diagnosis of periodontal diseases 258868 0
Condition category
Condition code
Oral and Gastrointestinal 259003 259003 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
The three trained examiners measured PD in the 20 patients to determine the intra- and inter-examiner reproducibility. PD is defined as the measurement in millimeters from the gingival margin to the bottom of the gingival sulcus. The study used a Williams manual periodontal probe (1, 2, 3, 5, 7, 8, 9 and 10 mm), introducing the probe in the interior of the gingival sulcus and following the length of the tooth until resistance was felt by the penetrating probe. Each patient had six sites probed per tooth (mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual), excluding third molars. The PD measurements were done using the following criteria: all measurements were rounded to the closest 0.5 mm (up or down) and when the PD measurement was exactly between two marks on the probe (except between 3 mm and 5 mm, where the middle measurement equaled 4 mm), the closest millimeter immediately above the mark was recorded. Each patient had to have a minimum of six teeth per quadrant in order to be included in the study. The initial probe depths (baseline) were taken using the following methodology: on Day 1, Examiner 1 did an initial PD (baseline); two days later (day 3), Examiner 2 did an initial PD; and on day 5, Examiner 3 did an initial PD. On day 7 the second round of PD began on the patient by Examiner 1, with Examiners 2 and 3 probing on days 9 and 11, respectively. This same methodology was used on all 20 patients until data was recorded for all of them. Each patient was probed a maximum of six times (two probes per examiner: the initial and the repeated probing). Therefore, the 20 patients were probed twice in different appointments by the three examiners. The sequence of the examiners was random (a lottery).
Intervention code [1] 257779 0
Diagnosis / Prognosis
Intervention code [2] 257780 0
Early detection / Screening
Comparator / control treatment
-Intra-examiner reproducibility: Comparison of initial probing depth measurements and repeated probing depth measurements by each examiner
-Inter- examiner reproducibility: between three examiners. Comparison of repeated measurements of each examiner with repeated measurements of others examiners on probing pocket depth with a manual periodontal probe on healthy patients.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259859 0
Primary Outcome 1: Assess the intra and inter-examiner reproducibility on clinical register of probing pocket depth in healthy patients (without periodontal disease) using a measurement tool (periodontal probe).
Timepoint [1] 259859 0
Timepoint: During a period of one month, the examiners selected subjects who will be participating in the study based on exclusion and inclusion criterions (subjects selection).
After selection of subjects, during a period of 4 months, the examiners worked on calibration process until demonstrate that they were calibrated (in subjects that was not part of the experimental group) according to parameters: Substantial kappa values, 90% agreement for +/- 1mm and an exact agreement in 75% of the PD repeated measurements.
Once the examiners demonstrated that they had been trained within the abovementioned parameters the study was initiated. Finally, 8 months after calibration to collect and assess the datas.
Secondary outcome [1] 268725 0
Secondary Outcome 1: To assess the reproducibility differences between the Probing depth with a manual probe on mesial tooth surfaces vs. distal tooth surfaces
Timepoint [1] 268725 0
Timepoint: 8 months after calibration to collect the datas.
Secondary outcome [2] 268726 0
Secondary Outcome 2: To assess the reproducibility differences between the Probing depth with a manual probe on anterior vs. posterior mouth areas.
Timepoint [2] 268726 0
Timepoint: 8 months after calibration to collect the datas.
Secondary outcome [3] 268727 0
Secondary Outcome 3: To assess the reproducibility differences between the Probing depth with a manual probe on buccal vs. lingual tooth surfaces.
Timepoint [3] 268727 0
Timepoint: 8 months after calibration to collect the datas.
Secondary outcome [4] 268728 0
Secondary Outcome 4: To assess the reproducibility differences between the Probing depth with a manual probe on superior vs. inferior dental arch.
Timepoint [4] 268728 0
Timepoint: 8 months after calibration to collect the datas.

Eligibility
Key inclusion criteria
Patients participating in the study could not have: a loss of clinical attachment levels; 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of periodontal disease (attachment lost or bone lost)

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
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] 3104 0
El Salvador
State/province [1] 3104 0

Funding & Sponsors
Funding source category [1] 258246 0
Self funded/Unfunded
Name [1] 258246 0
Country [1] 258246 0
Primary sponsor type
Individual
Name
Roberto Antonio Andrade Acevedo
Address
Centro de Salud Integral 4212. Colonia Escalon. San Salvador, El Salvador, Central America
Country
El Salvador
Secondary sponsor category [1] 257415 0
None
Name [1] 257415 0
Address [1] 257415 0
Country [1] 257415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260225 0
CIE. Institutional Ethics Comite of Universidad Evangelica de El Salvador (Evangelic University of El Salvador)
Ethics committee address [1] 260225 0
Ethics committee country [1] 260225 0
El Salvador
Date submitted for ethics approval [1] 260225 0
05/10/2008
Approval date [1] 260225 0
05/11/2008
Ethics approval number [1] 260225 0
Certificate assessment of clinical study n0 9

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

Contacts
Principal investigator
Name 32039 0
Address 32039 0
Country 32039 0
Phone 32039 0
Fax 32039 0
Email 32039 0
Contact person for public queries
Name 15286 0
Roberto Antonio Andrade Acevedo
Address 15286 0
Centro de Salud Integral 4212. Colonia Escalon, San Salvador, Central America.
Country 15286 0
El Salvador
Phone 15286 0
+(503) 2264 6321 (for San Salvador, El Salvador, Central America)
Fax 15286 0
+(503) 2275 4000-ext 4052
Email 15286 0
robertoandrade_periodoncia@yahoo.com.br, robertoandrade67@yahoo.com.br, acevedoroberto@hotmail.com.
Contact person for scientific queries
Name 6214 0
Roberto Antonio Andrade Acevedo
Address 6214 0
Centro de Salud Integral 4212. Colonia Escalon, San Salvador, Central America.
Country 6214 0
El Salvador
Phone 6214 0
+(503) 2264 6321 (for San Salvador, El Salvador, Central America)
Fax 6214 0
+(503) 2275 4000-ext 4052
Email 6214 0
robertoandrade_periodoncia@yahoo.com.br, robertoandrade67@yahoo.com.br, acevedoroberto@hotmail.com.

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

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

Documents added automatically
No additional documents have been identified.