About this trial
The goal of this study is to evaluate the efficacy of autologous dentin graft (ADG) in treating periodontal defects on the distal aspect of mandibular 2nd molar (M2) after surgical removal of impacted mandibular 3rd molar (M3) by improving periodontal and radiological outcomes when compared with a xenograft, which is commercially available. The main questions it aims to answer are:
1. How does the clinical efficacy of ADG compare to xenografts, regarding wound healing and periodontal parameters at the distal aspect of periodontally compromised mandibular M2 following impacted M3 extraction? 2. How does the radiological bone regeneration at ADG-grafted sites differ from that at xenograft-grafted sites? 3. How do the post-operative patient-reported outcomes at sites receiving ADG differ from those at sites receiving xenografts?
Researchers will compare ADG to xenograft to see if ADG is more efficacious in managing periodontal defects on distal aspect of M2 after surgical removal of M3.
Participants will
1. Undergo bilateral surgical removal of M3 under general anaesthesia 2. Receive ADG on test site and xenograft on contralateral control site 3. Come back for clinical assessments, wound healing assessments and radiographic assessments for 5 times after the surgery (2 weeks, 1 month, 3 months, 6 months and 12 months)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 26 years and above who can give informed consent and are scheduled for bilateral surgical removal of mesioangular or horizontally impacted mandibular M3s
Present with a periodontally compromised mandibular second molar, defined by the presence of probing pocket depth (PPD) greater than 4 mm on the distal aspect
Type of impaction of M3s on both sides must be symmetrical
Consent to the use of xenograft as control
Disqualifiers
Smokers
Poor oral hygiene with >30% full mouth plaque score (FMPS)
Pregnant or lactating mothers
Have uncontrolled systemic conditions such as diabetes or immunodeficiency disorders
Trial design
Parallel
Treatments tested in this trial
Autologous dentin graft
Biological/VaccineExtracted mandibular M3 will be mechanically processed intraoperatively into dentine particles using the BonMaker® device (Korea Dental Solutions Co. Ltd., South Korea), in accordance with the manufacturer's instructions for chairside preparation of ADG.
Xenograft
Biological/VaccineCommercially available xenograft, which is of bovine derivative
Treatment groups
Trial outcomes
Primary outcomes
Clinical Assessment
Probing pocket depth (PPD) (mm)
Clinical Assessment
Clinical attachment level (CAL) (mm)
Radiographic Assessment
Osseous defect depth (ODD)
Secondary outcomes
Wound Healing Assessment
Landry Wound Healing Index
Patient Reported Outcome Measures
Visual Analogue Scales (VAS) will be used to capture post-operative pain. 100 mm VAS ruler will be used, where the scale is from 0 (no pain) to 100 (worst pain imaginable).
Patient Reported Outcome Measures
Pain Intensity Score from the Malay validated version of the Brief Pain Inventory (BPI) questionnaire will be used. This section consists of 4 questions where the scale is from 0 (no pain) to 10 (worst pain imaginable).
Patient Reported Outcome Measures
Pain Interference Score from the Malay validated version of the Brief Pain Inventory (BPI) questionnaire will be used. This section consists of 7 questions where the scale is from 0 (does not interfere) to 10 (completely interferes).
Other outcomes
Clinical Assessment
Plaque index (PI)(%)
Clinical Assessment
Bleeding on probing (BOP)(%)
Radiographic Assessment
Advanced radiomic analysis will be conducted using LifeX, a dedicated and validated radiomics software platform, to extract detailed quantitative features of trabecular bone microarchitecture, expressed in the form of grayscale value.
Sponsors and contacts
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