Impacted Mandibular Third Molar ExtractionNCT07362394
Autologous Dentine Graft Compared to Xenograft in Managing Periodontally Compromised Second Molar After Third Molar Removal
A study testing Autologous dentin graft and Xenograft in people with Impacted Mandibular Third Molar Extraction and Dentin Graft, run by National University of Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction, Dentin Graft, Xenograft
- What is being tested?
- Autologous dentin graft and Xenograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Kuala Lumpur Hospital
Kuala Lumpur, Kuala Lumpur, 50586
Rengarajoo Jonathan, +60326155555, jonathanrengarajoo@moh.gov.my
About this study
Official title: Autologous Dentine Graft Compared to Xenograft in Managing Periodontally Compromised Second Molar After Third Molar Removal - A Split-Mouth Randomized Controlled Trial
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:
- 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?
- How does the radiological bone regeneration at ADG-grafted sites differ from that at xenograft-grafted sites?
- How do the post-operative patient-reported outcomes at sites receiving ADG differ from those at sites receiving xenografts?
Read more
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
- Undergo bilateral surgical removal of M3 under general anaesthesia
- Receive ADG on test site and xenograft on contralateral control site
- 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)
- Being tested
- Autologous dentin graft, Xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dentin graftBiological
Also called Autogenous dentin graft, autogenous tooth bone graft, demineralised dentin matrix
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.
XenograftBiological
Commercially available xenograft, which is of bovine derivative
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Autologous dentin graft |
| Xenograft Group | Active comparator | Xenograft will be placed using the same placement technique as that employed in the ADG group. Receives: Biological: Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment
Probing pocket depth (PPD) (mm)
Measured: Baseline, 3 months, 6 months, 12 months
Clinical Assessment
Clinical attachment level (CAL) (mm)
Measured: Baseline, 3 months, 6 months, 12 months
Radiographic Assessment
Osseous defect depth (ODD)
Measured: Baseline, 6 months, 12 months
Secondary outcomes (4)
Wound Healing Assessment
Landry Wound Healing Index
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nik Madihah Nik Aziz, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362394
- Sponsor's protocol ID
- UKM-FGG-ADG25
- Other IDs
- RSCH ID-25-08139-VWQ
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect confidentiality of study subjects
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Dentine Graft Compared to Xenograft in Managing Periodontally Compromised Second Molar After Third Molar Removal - A Split-Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07362394
- Acronym / sponsor ID
- UKM-FGG-ADG25
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- How does the radiological bone regeneration at ADG-grafted sites differ from that at xenograft-grafted sites?
- 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
- Undergo bilateral surgical removal of M3 under general anaesthesia
- Receive ADG on test site and xenograft on contralateral control site
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ADG Group | Experimental | Biological: Autologous dentin graftADG will be immediately packed into the extraction socket against the distal root of M2 until cementoenamel junction (CEJ) level, before flap repositioning and suturing. |
| Xenograft Group | Active comparator | Biological: XenograftXenograft will be placed using the same placement technique as that employed in the ADG group. |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous dentin graftAlso: Autogenous dentin graft, autogenous tooth bone graft, demineralised dentin matrixExtracted 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. | Biological | ADG Group |
| XenograftCommercially available xenograft, which is of bovine derivative | Biological | Xenograft Group |
Primary outcome
Clinical Assessment
Time frame: Baseline, 3 months, 6 months, 12 months
Probing pocket depth (PPD) (mm)
Clinical Assessment
Time frame: Baseline, 3 months, 6 months, 12 months
Clinical attachment level (CAL) (mm)
Radiographic Assessment
Time frame: Baseline, 6 months, 12 months
Osseous defect depth (ODD)
4 secondary outcomes
Wound Healing Assessment
Time frame: Baseline, 2 weeks, 1 month, 3 months, 6 months and 12 months
Patient Reported Outcome Measures
Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
Patient Reported Outcome Measures
Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
Patient Reported Outcome Measures
Time frame: Baseline, Day 1, Day 3, 1 week, 2 weeks, 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. To protect confidentiality of study subjects
Related trials for Impacted Mandibular Third Molar Extraction
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Active, not recruiting
Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
Facial Swelling, Tooth Position Anomalies
Recruiting
Demineralized Dentin Allograft Versus Demineralized Dentin Autograft for Socket Preservation
Alveolar Bone Loss
Recruiting
Comparison of PRF and Corticosteroids in Impacted Third Molar Surgery
Impacted Mandibular Third Molar Extraction, Impacted Lower Third Molar
Not yet recruiting
Comparison of Electrocautery and Scalpel Blade Incisions of Impacted Mandibular Third Molars
Impacted Mandibular Third Molar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous dentin graft and Xenograft in people with Impacted Mandibular Third Molar Extraction and Dentin Graft, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chee Shoon Chow (+60174165633, p161908@siswa.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment (time frame: Baseline, 3 months, 6 months, 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.