Accuracy of dental x-ray in diagnosis of tooth bone loss
| ISRCTN | ISRCTN89375372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89375372 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Universiti Teknologi MARA |
| Funder | Institute of Research Management and Innovation, Universiti Teknologi MARA |
- 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
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
Scientific
Universiti Teknologi MARA (UiTM)
Sungai Buloh Campus
Faculty of Dentistry
Jalan Hospital
Sungai Buloh
Selangor
47000
Malaysia
 ORCID ID |
0000-0002-1529-5134 |
|---|---|
| Phone | +60 195643924 |
| 2016631512@isiswa.uitm.edu.my |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel randomized single-blinded single centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Diagnostic accuracy of periapical radiograph, cone-beam computed tomography, and intrasurgical measurement techniques for assessing furcation defects |
| Study objectives | There 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) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
During periodontal surgery: |
| Completion date | 01/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 22 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 01/01/2020 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Jalan Hospital
Sungai Buloh
47000
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/01/2022: Publication reference added.
10/01/2020: Trial’s existence confirmed by Ethics Committee of Universiti Teknologi MARA
