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Not yet recruiting NCT07362394

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

No phase Interventional Impacted Mandibular Third Molar Extraction Dentin Graft Xenograft Bone Defects

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous dentin graft, Xenograft.
Who it may be relevant to
Registry conditions: Impacted Mandibular Third Molar Extraction, Dentin Graft, Xenograft, Bone Defects. Basic parameters: from 26 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Autologous Dentine Graft Compared to Xenograft in Managing Periodontally Compromised Second Molar After Third Molar Removal - A Split-Mouth Randomized Controlled Trial

Overview

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)

Interventions

  • Biological Autologous dentin graft
    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.
  • Biological Xenograft
    Commercially available xenograft, which is of bovine derivative

Primary outcome measures

  • Clinical Assessment [Time frame: Baseline, 3 months, 6 months, 12 months]
  • Clinical Assessment [Time frame: Baseline, 3 months, 6 months, 12 months]
  • Radiographic Assessment [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (4)
  • Wound Healing Assessment [Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months and 12 months]
  • Patient Reported Outcome Measures [Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month]
  • Patient Reported Outcome Measures [Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month]
  • Patient Reported Outcome Measures [Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • On medications that affect bone metabolism, including bisphosphonates or corticosteroids
  • History of periodontal surgery or grafting at the intended surgical site
  • Presence of acute infection and M2s with distal caries and Grade III mobility

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • Kuala Lumpur Hospital — Kuala Lumpur

Identifiers

NCT: NCT07362394 · UKM-FGG-ADG25 · RSCH ID-25-08139-VWQ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗