Soft and Hard Tissue Healing Following Alveolar Ridge Preservation of Mandibular Third Molar Extraction Socket Filled With Auto Tooth Bone Graft or Alloplastic Graft

NCT07723183 | Completed Phase 4 DMC

• 2 other identifiers: DF OS2316/0084 (P)UMG027E-2023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared two bone graft materials: 1. Auto Tooth Bone (ATB) (made from the patient's own extracted tooth) and 2. EthOss® a synthetic alternative. This is to see how well they prevent bone and gum damage after lower wisdom tooth removal. In this split-mouth trial, participants had both lower wisdom teeth removed, with one socket receiving ATB and the other receiving EthOss®. Over a 24-week follow-up period, researchers tracked patient clinically on their comfort, gum healing, and new bone growth using X-rays. The study found that both materials performed similarly and showing no significant differences in pain, swelling, complications, or gum healing. While there was a statistical difference in final bone depth. Both grafts successfully stimulated new bone growth, proving that ATB and EthOss® are equally safe, reliable, and effective options for supporting recovery after wisdom tooth surgery.

Conditions

Wisdom Tooth; Socket Preservation

Keywords

bone substitutes; allplastic; alveolar ridge augmentation; periodontal defect

Outcome Measures

Primary Outcomes (1)

• Periodontal health assessment on lower second molar

  1. Modified Plaque Score (from Score 0: No plaque present. Score 1: No visible plaque, but a periodontal probe skimmed across the tooth surface reveals soft plaque biofilm on the tip. Score 2: Visible plaque that can be easily seen with the naked eye without using a probe., modified bleeding score and gingival recession, periodontal pocketing depth)-- the lower the score, the better the periodontal health. 2. Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health. 3. Periodontal Pocketing Depth (PPD) (measurement in milimeter, 1-3mm indicate healthy sulcus while \>5mm indicate periodontal disesase)-- the lower the score, the better the periodontal health. 4. Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health.

  baseline on day of surgery, 12 weeks and 24 weeks after surgery

Secondary Outcomes (1)

• Bone gain

  radiograph taken prior to surgery and 24 weeks after surgery

Other Outcomes (1)

• Pain, swelling and mouth opening

  Prior to surgery, 1 week and 4 weeks after the surgery

Study Arms (2)

Auto Tooth Graft

ACTIVE COMPARATOR

This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. Auto Tooth Graft and Intervention 2. Ethoss alloplast material simultaneously on opposite sides of the lower third molar

Combination Product: auto tooth graft material

Ethoss

ACTIVE COMPARATOR

This is a split-mouth, randomized, within-subject clinical trial using a crossover assignment model. Each participant serves as their own control, receiving both Intervention 1. Auto Tooth Graft and Intervention 2. Ethoss alloplast material simultaneously on opposite sides of the lower third molar

Combination Product: auto tooth graft material

Interventions

auto tooth graft material COMBINATION_PRODUCT

auto tooth graft (dentin graft) is taken from patient's extracted lower wisdom tooth. Ethoss is a synthetic material

Auto Tooth Graft; Ethoss

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient who requires surgical removal of bilateral impacted M3.
• Patient with impacted bilateral M3 which are sound.
• Impacted bilateral M3 classified as Class I or II with Level A or B according to Pell and Gregory's classification.
• Presence of M2 adjacent to the M3 to be extracted.
• Patient aged 18 to 35 years old.
• Patient with periodontal status of:
• Basic Periodontal Score (BPE) 2 at lower right and lower left sextants.
• Full mouth plaque score \<30%.

You may not qualify if:

• Impacted M3 associated in the following conditions:
• Fracture of angle of mandible.
• Radiological evidence of cyst or tumour.
• Incomplete root formation.
• Acute pulpitis or severe pericoronitis that is not under-controlled.
• Gross dental caries.
• Retained roots of mandibular third molar with history of removal of unerupted/impacted M3.
• Patient's age \<18 years old or \> 35 years old
• M2 with periapical inflammation, periodontitis, distal caries or delayed or non-responsive pulp sensibility test to exclude tooth with perio-endo lesion.
• Pregnant woman.
• Patient on oral contraceptives.
• Current or previous bisphosphonate therapy or history of radiotherapy to the jaws.
• Active smoker.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry Universiti Malaya

Kuala Lumpur, Wilayah Perseketuan Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• 1. NICE. Guidance on the Extraction of Wisdom Teeth. NICE Guidance 2000. Available from: www.nice.org.uk/guidance/ta1/chapter/2-Clinical-need-and-practice (accessed 2026 June 9). 2. Kan KW, Liu JK, Lo EC, Corbet EF, Leung WK. Residual periodontal defects distal to the mandibular second molar 6-36 months after impacted third molar extraction. J Clin Periodontol 2002:29:1004-1011. doi: 10.1034/j.1600-051x.2002.291105.x. 3. Renton T, Coulthard P, Chiu G, Master S, Brookes V, Atack N, et al. Parameters of care for patients undergoing mandibular third molar surgery. Faculty of Dental Surgery, The Royal College of Surgeons of England. 2020. Available from: www.rcseng.ac.uk/-/media/files/rcs/fds/guidelines/3rd-molar-guidelines--april-2021.pdf (accessed 2026 June 9). 4. Zhang Y, Chen X, Zhou Z, Hao Y, Li H, Cheng Y, et al. Effects of Impacted Lower Third Molar Extraction on Periodontal Tissue of the Adjacent Second Molar. Ther Clin Risk Manag 2021:17:235-247. doi: 10.2147/TCRM.S298147. 5. Bouloux GF, Steed MB, Perciaccante VJ. Complications of third molar surgery. Oral Maxillofac Surg Clin North Am 2007:19:117-128, vii. doi: 10.1016/j.coms.2006.11.013. 6. Cho H, Lynham AJ, Hsu E. Postoperative interventions to reduce inflammatory complications after third molar surgery: review of the current evidence. Aust Dent J 2017:62:412-419. doi: 10.1111/adj.12526. 7. Kumar N, Prasad K, Ramanujam L, K R, Dexith J, Chauhan A. Evaluation of treatment outcome after impacted mandibular third molar surgery with the use of autologous platelet-rich fibrin: a randomized controlled clinical study. J Oral Maxillofac Surg 2015:73:1042-1049. doi: 10.1016/j.joms.2014.11.013. 8. Nguyen NT, Le SH, Nguyen BT. The effect of autologous demineralized dentin matrix on postoperative complications and wound healing following lower third molar surgery: A split-mouth randomized clinical trial. J Dent Sci 2025:20:553-559. doi: 10.1016/j.jds.2024.04.026. 9. Peng KY, Tseng YC, Shen EC, Chiu SC, Fu E, Huang YW. M

  BACKGROUND

Study Officials

• Chuey Chuan Tan, MClinDent (OMFS)

  Universiti Malaya, Malaysia

  PRINCIPAL INVESTIGATOR

• Wei Cheong Ngeow, Phd

  University of Malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient and surgeons are masking from the usage of different bone graft materials
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr

Model Details: This is a split mouth study, within a single patient auto tooth graft and allograft (Ethoss) placed on each side of lower wisdom tooth socket.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)