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
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