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| ID | Type | Description | Link |
|---|---|---|---|
| RSCH ID-25-08139-VWQ | Other Identifier | Malaysia National Medical Research Register |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Xenograft Group | Active Comparator | Xenograft will be placed using the same placement technique as that employed in the ADG group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Assessment | Plaque index (PI)(%) | Baseline, 1 month, 3 months, 6 months, 12 months |
| Clinical Assessment | Bleeding on probing (BOP)(%) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chee Shoon Chow | Contact | +60174165633 | p161908@siswa.ukm.edu.my | |
| Nik Azis Nik Madihah | Contact | +603 92897745 | nikmadihah@ukm.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuala Lumpur Hospital | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
To protect confidentiality of study subjects
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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.
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| Xenograft | Biological | Commercially available xenograft, which is of bovine derivative |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D014183 | Transplantation, Heterologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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