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NCT Number: NCT07362394

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

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)

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Key information

Conditions

Impacted Mandibular Third Molar Extraction Bone Defects Dentin Graft Xenograft

Age range

26 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Autogenous dentin graft, autogenous tooth bone graft, demineralised dentin matrix

Xenograft

Biological

Commercially available xenograft, which is of bovine derivative

Primary outcomes

  1. Clinical Assessment

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

    Probing pocket depth (PPD) (mm)

  2. Clinical Assessment

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

    Clinical attachment level (CAL) (mm)

  3. Radiographic Assessment

    Time frame: Baseline, 6 months, 12 months

    Osseous defect depth (ODD)

Secondary outcomes

  1. Wound Healing Assessment

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

    Landry Wound Healing Index

  2. Patient Reported Outcome Measures

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

    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).

  3. Patient Reported Outcome Measures

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

    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).

  4. Patient Reported Outcome Measures

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

    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

  1. Clinical Assessment

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

    Plaque index (PI)(%)

  2. Clinical Assessment

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

    Bleeding on probing (BOP)(%)

  3. Radiographic Assessment

    Time frame: Baseline, 6 months, 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chee Shoon Chow

CONTACT

[email protected]

+60174165633

Nik Azis Nik Madihah

CONTACT

[email protected]

+603 92897745

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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