Condition category
Oral Health
Date applied
29/12/2019
Date assigned
10/01/2020
Last edited
10/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In dentistry, a furcation defect is bone loss, usually a result of periodontal disease, affecting the base of the root trunk of a tooth where two or more roots meet (bifurcation or trifurcation). The extent and configuration of the defect are factors in both diagnosis and treatment planning.
This study aims to compare three methods of assessing furcation defects.

Who can participate?
Patients aged 18 years or above diagnosed with periodontitis and a furcation defect.

What does the study involve?
Particpants will be assessed using periapical radiographs, cone beam computed tomography (CBCT), and intrasurgical measurements.

What are the possible benefits and risks of participating?
This study can provide benefits to the patients and clinicians in guiding future techniques for tooth examination.
There are no risks expected.

Where is the study run from?
Universiti Teknologi MARA, Sungai Buloh Campus, Malaysia

When is the study starting and how long is it expected to run for?
September 2017 to January 2020

Who is funding the study?
Universiti Teknologi MARA, Malaysia

Who is the main contact?
Dr Nurul Ain Mohamed Yusuf
ainyusof12@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nurul Ain Mohamed Yusof

ORCID ID

http://orcid.org/0000-0002-1529-5134

Contact details

Universiti Teknologi MARA (UiTM)
Sungai Buloh Campus
Faculty of Dentistry
Jalan Hospital
Sungai Buloh
Selangor
47000
Malaysia
+60 195643924
2016631512@isiswa.uitm.edu.my

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Diagnostic accuracy of periapical radiograph, cone-beam computed tomography, and intrasurgical measurement techniques for assessing furcation defects

Acronym

Study hypothesis

There will be no differences in the linear measurements of furcation defects between CBCT, periapical radiograph, and intrasurgical values

Ethics approval

Approved 20/08/2017, Ethical Committee of Universiti Teknologi MARA (, Aras 3, Bangunan Wawasan, 40450 Shah Alam, Selangor, MALAYSIA, +60 3-55442094; irmiuitm@uitm.edu.my ), ref: REC/295/17

Study design

Parallel randomized single-blinded single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Periodontitis patients that have molar with furcation defects

Intervention

To evaluate the differences in terms of the linear measurements of furcation defects between periapical radiographs, cone beam computed tomography (CBCT), and intrasurgical measurements

Patients will be randomised to be measured using a combination of CBCT and intrasurgical measurements, or periapical radiographs and intrasurgical measurements.

Randomisation and allocation concealment of patients were performed using sequentially numbered, opaque sealed envelopes (SNOSE).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

The extent and severity of furcation defects in molar teeth, including CEJ-BD (clinical attachment loss), BL-H (depth of furcation defect), BL-V (height of furcation defect), RT (root trunk), and FW (width of the furcation defect) measured by radiographs during periodontal surgery

Secondary outcome measures

During periodontal surgery:
1. Probing pocket depth (PPD) (mm) measured by visual inspection
2. Full mouth plaque score measured by visual inspection
3. Full mouth bleeding score measured by visual inspection

Overall trial start date

01/09/2017

Overall trial end date

01/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of moderate to severe chronic periodontitis according to American Academy of Periodontology (AAP) 1999 classification workshop, or Periodontitis Stage III or IV according to AAP 2017 classification
2. Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) ≤ 15%
3. Presence of at least one molar with furcation involvement Class II or III with probing pocket depth (PPD) of ≥ 6 mm that is indicated for periodontal surgery
4. Identifiable cementoenamel junction (CEJ)
5. Ability to sit for all required radiographic surveys

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

22

Participant exclusion criteria

1. Patients with uncontrolled systemic disease
2. Smoker
3. Pregnant and lactating women
4. Patients with furcation caries
5. Patients with metal crowns in the furcation area or silver amalgam fillings near the alveolar crest
6. Molar with furcation involvement that is indicated for extraction
7. Third molars

Recruitment start date

01/09/2017

Recruitment end date

01/01/2020

Locations

Countries of recruitment

Malaysia

Trial participating centre

Universiti Teknologi MARA, Sungai Buloh Campus
Faculty of Dentistry Jalan Hospital
Sungai Buloh
47000
Malaysia

Sponsor information

Organisation

Universiti Teknologi MARA

Sponsor details

Faculty of Dentistry
Sungai Buloh Campus
Jalan Hospital
Sungai Buloh
Shah Alam
47000
Malaysia
+60 361266161
yusmiaidil@uitm.edu.my

Sponsor type

University/education

Website

http://www.uitm.edu.my/index.php/en

Funders

Funder type

University/education

Funder name

Institute of Research Management and Innovation, Universiti Teknologi MARA

Alternative name(s)

Institute of Research Management & Innovation, IRMI, UiTM

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

Malaysia

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

30/03/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/01/2020: Trial’s existence confirmed by Ethics Committee of Universiti Teknologi MARA