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

National University of Malaysia

Status: Begins enrollment in 3 months

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

Treatments: Biological: Autologous dentin graft; Biological: Xenograft

Study type: Interventional

Funder types: Other

Identifiers

NCT07362394

RSCH ID-25-08139-VWQ (Other Identifier)

UKM-FGG-ADG25

Details and patient eligibility

About

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)

Enrollment: 34 estimated patients

Sex: All

Ages: 26+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

ADG Group

Experimental group

Description:

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.

Treatment:

Biological: Autologous dentin graft

Xenograft Group

Active Comparator group

Description:

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

Treatment:

Biological: Xenograft