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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Defects; Dentin Graft; Impacted Mandibular Third Molar Extraction; Xenograft
• Intervention / Treatment: Biological: Autologous dentin graft; Biological: Xenograft

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chee Shoon Chow; Phone Number: +60174165633; Email: p161908@siswa.ukm.edu.my
• Study Contact Backup: Name: Nik Azis Nik Madihah; Phone Number: +603 92897745; Email: nikmadihah@ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
      • Kuala Lumpur Hospital
      • Contact: Rengarajoo Jonathan; Phone Number: +60326155555; Email: jonathanrengarajoo@moh.gov.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADG Group; ADG will be immediately packed into the extraction socket against the distal root of M2 until cementoenamel junction (CEJ) level, before flap repositioning and suturing.	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.; Other Names: Autogenous dentin graft; autogenous tooth bone graft; demineralised dentin matrix
Active Comparator: Xenograft Group; Xenograft will be placed using the same placement technique as that employed in the ADG group.	Biological: Xenograft; Commercially available xenograft, which is of bovine derivative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Assessment	Probing pocket depth (PPD) (mm)	Baseline, 3 months, 6 months, 12 months
Clinical Assessment	Clinical attachment level (CAL) (mm)	Baseline, 3 months, 6 months, 12 months
Radiographic Assessment	Osseous defect depth (ODD)	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing Assessment	Landry Wound Healing Index	Baseline, 2 weeks, 1 month, 3 months, 6 months and 12 months
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).	Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
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).	Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
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).	Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Assessment	Plaque index (PI)(%)	Baseline, 1 month, 3 months, 6 months, 12 months
Clinical Assessment	Bleeding on probing (BOP)(%)	Baseline, 1 month, 3 months, 6 months, 12 months
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.	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Transplantation; Transplantation, Heterologous
• Other Study ID Numbers: UKM-FGG-ADG25; RSCH ID-25-08139-VWQ (Other Identifier: Malaysia National Medical Research Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect confidentiality of study subjects

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No