Impacted Mandibular Third Molar Extraction, Dentin Graft, Xenograft, Bone Defects
Conditions
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. 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
BIOLOGICALAutologous 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.
BIOLOGICALXenograft
Commercially available xenograft, which is of bovine derivative
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
26 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessment | Baseline, 3 months, 6 months, 12 months | Probing pocket depth (PPD) (mm) |
| Radiographic Assessment | Baseline, 6 months, 12 months | Osseous defect depth (ODD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Assessment | Baseline, 2 weeks, 1 month, 3 months, 6 months and 12 months | Landry Wound Healing Index |
| Patient Reported Outcome Measures | 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). |
Countries
Malaysia
Contacts
CONTACTChee Shoon Chow
CONTACTNik Azis Nik Madihah
Outcome results
None listed