Accuracy of dental x-ray in diagnosis of tooth bone loss

ISRCTN ISRCTN89375372
DOI https://doi.org/10.1186/ISRCTN89375372
Submission date
29/12/2019
Registration date
10/01/2020
Last edited
14/01/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Nurul Ain Mohamed Yusof
Scientific

Universiti Teknologi MARA (UiTM)
Sungai Buloh Campus
Faculty of Dentistry
Jalan Hospital
Sungai Buloh
Selangor
47000
Malaysia

ORCiD logoORCID ID 0000-0002-1529-5134
Phone +60 195643924
Email 2016631512@isiswa.uitm.edu.my

Study information

Study designParallel randomized single-blinded single centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDiagnostic accuracy of periapical radiograph, cone-beam computed tomography, and intrasurgical measurement techniques for assessing furcation defects
Study objectivesThere will be no differences in the linear measurements of furcation defects between CBCT, periapical radiograph, and intrasurgical values
Ethics approval(s)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
Health condition(s) or problem(s) studiedPeriodontitis patients that have molar with furcation defects
InterventionTo 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 typeProcedure/Surgery
Primary outcome measureThe 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 measuresDuring 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 study start date01/09/2017
Completion date01/01/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants22
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2017
Date of final enrolment01/01/2020

Locations

Countries of recruitment

  • Malaysia

Study participating centre

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

Sponsor information

Universiti Teknologi MARA
University/education

Faculty of Dentistry
Sungai Buloh Campus
Jalan Hospital
Sungai Buloh
Shah Alam
47000
Malaysia

Phone +60 361266161
Email yusmiaidil@uitm.edu.my
Website http://www.uitm.edu.my/index.php/en
ROR logo "ROR" https://ror.org/05n8tts92

Funders

Funder type

University/education

Institute of Research Management and Innovation, Universiti Teknologi MARA
Private sector organisation / Research institutes and centers
Alternative name(s)
Institute of Research Management & Innovation, IRMI, UiTM
Location
Malaysia

Results and Publications

Intention to publish date30/03/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 14/06/2020 14/01/2022 Yes No

Editorial Notes

14/01/2022: Publication reference added.
10/01/2020: Trial’s existence confirmed by Ethics Committee of Universiti Teknologi MARA