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Completed

NCT Number: NCT07723183

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

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.

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Key information

Conditions

Wisdom Tooth Socket Preservation

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry Universiti Malaya

Kuala Lumpur, Wilayah Perseketuan Kuala Lumpur, 50603, Malaysia

About this study

Surgical removal of impacted mandibular third molars may lead to complications that include periodontal defects at the second molar. Alveolar socket preservation with graft material can reduce this complication. This study aims to assess the soft and hard tissue healing of the surgical sites following the removal of impacted mandibular third molars with alveolar socket preservation using auto tooth bone graft (ATB) or EthOss® alloplastic graft and comparing for any difference between both grafts. This is a split-mouth, double blinded, randomized controlled study. Participants underwent surgical removal of bilateral impacted mandibular third molars with either socket filled with ATB or EthOss® alloplastic graft. The participants were reviewed 1 week and 4 weeks post-operative for signs of graft reaction/rejection. Periodontal assessments were performed at post-operative week 12 and 24 to assess the soft tissue healing. Radiological assessment was done at post-operative week 24 to assess bone depth. There was no significant difference between ATB and EthOss® graft in the healing of the soft tissue adjacent to the sockets, post-operative sequelae (pain, trismus and facial swelling) or post-operative complications. However, a statistically significant difference was observed in bone depth within both groups. The healing outcomes and bone quality achieved with ATB and EthOss® are comparable. Both materials have demonstrated effective osteoconductive properties, making them reliable materials for bone regeneration. This equivalency in clinical performance supports the use of either material as viable alternatives for bone regeneration procedures with predictable results.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Periodontal health assessment on lower second molar

    Time frame: baseline on day of surgery, 12 weeks and 24 weeks after surgery

    • 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.
    • Modified Bleeding Score (Score 0: No bleeding observed after probing. Score 1: Bleeding is present.)-- the lower the score, the better the periodontal health.
    • 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.
    • Gingival Recession- measurement in mm for gingival margin below the cementoenamel junction. - the lower the score, the better the periodontal health.

Secondary outcomes

  1. Bone gain

    Time frame: radiograph taken prior to surgery and 24 weeks after surgery

    Comparing bone gain in lower third molar socket by comparing pre operative and post operative radiograph. Measurement in milimeter.

Other outcomes

  1. Pain, swelling and mouth opening

    Time frame: Prior to surgery, 1 week and 4 weeks after the surgery

    clinical measurement of the mouth opening (in milimeter) and pain (Visual analog scale 0 to 10 from no pain to most pain) and swelling of the cheek (measured as the sum of the length of the two lines along the pre-determined facial reference points from the outer corner of the eye to the angle of mandible and tragus of the ear to the corner of the mouth. This was performed using a measuring tape. The percentage of facial swelling was calculated based on the differences between baseline measurements with measurements taken during baseline)

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Acronym: AutoToothGraft

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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