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

NCT07362394 | Not Yet Recruiting

• 2 other identifiers: UKM-FGG-ADG25RSCH ID-25-08139-VWQ
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.How does the radiological bone regeneration at ADG-grafted sites differ from that at xenograft-grafted sites?
3. 3.How do the post-operative patient-reported outcomes at sites receiving ADG differ from those at sites receiving xenografts?
4. 4.Undergo bilateral surgical removal of M3 under general anaesthesia
5. 5.Receive ADG on test site and xenograft on contralateral control site
6. 6.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)

Conditions

Dentin Graft; Xenograft; Bone Defects; Impacted Mandibular Third Molar Extraction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Wound Healing Assessment

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

• Patient Reported Outcome Measures

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

• Patient Reported Outcome Measures

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

• Patient Reported Outcome Measures

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

Other Outcomes (3)

• Clinical Assessment

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

• Clinical Assessment

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

• Radiographic Assessment

  Baseline, 6 months, 12 months

Study Arms (2)

ADG Group

EXPERIMENTAL

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

Xenograft Group

ACTIVE COMPARATOR

Xenograft will be placed using the same placement technique as that employed in the ADG group.

Biological: Xenograft

Interventions

Xenograft BIOLOGICAL

Commercially available xenograft, which is of bovine derivative

Xenograft Group

Autologous dentin graft BIOLOGICAL

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.

Also known as: Autogenous dentin graft, autogenous tooth bone graft, demineralised dentin matrix

ADG Group

Eligibility Criteria

• Age: 26 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Kuala Lumpur Hospital

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Central Study Contacts

Chee Shoon Chow

CONTACT

+60174165633; p161908@siswa.ukm.edu.my

Nik Azis Nik Madihah

CONTACT

+603 92897745; nikmadihah@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and Clinical Specialist in Periodontology

Model Details: This study will be conducted as a prospective, double-blinded, split-mouth, randomised controlled trial to evaluate the efficacy of autologous dentine grafts (ADGs) compared to commercially available xenografts in promoting periodontal and alveolar bone healing at distal surface of M2s following the surgical removal of impacted mandibular M3s. Participants will be enrolled in a randomised split-mouth design. In each patient, one extraction socket (control site) will be grafted with a commercially available xenograft material, while the contralateral socket (test site) will be grafted with an ADG, prepared intraoperatively from the patient's own extracted M3.

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 23, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)