Autologous Dentine Graft Compared to Xenograft in Managing Periodontally Compromised Second Molar After Third Molar Removal

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age26+
SponsorNational University of Malaysia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Autologous dentin graft

    Biological/Vaccine

    Extracted 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/Vaccine

    Commercially available xenograft, which is of bovine derivative

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: ADG GroupExperimental treatment 1 intervention
Group B: Xenograft GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Assessment

Probing pocket depth (PPD) (mm)

Time frame
Baseline, 3 months, 6 months, 12 months
2

Clinical Assessment

Clinical attachment level (CAL) (mm)

Time frame
Baseline, 3 months, 6 months, 12 months
3

Radiographic Assessment

Osseous defect depth (ODD)

Time frame
Baseline, 6 months, 12 months

Secondary outcomes

1

Wound Healing Assessment

Landry Wound Healing Index

Time frame
Baseline, 2 weeks, 1 month, 3 months, 6 months and 12 months
2

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).

Time frame
Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
3

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).

Time frame
Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
4

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).

Time frame
Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month

Other outcomes

1

Clinical Assessment

Plaque index (PI)(%)

Time frame
Baseline, 1 month, 3 months, 6 months, 12 months
2

Clinical Assessment

Bleeding on probing (BOP)(%)

Time frame
Baseline, 1 month, 3 months, 6 months, 12 months
3

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.

Time frame
Baseline, 6 months, 12 months

Sponsors and contacts

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