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

26 juli 2026 uppdaterad av: Tan Chuey Chuan, University of Malaya
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Malaysia
    • Wilayah Perseketuan Kuala Lumpur
      • Kuala Lumpur, Wilayah Perseketuan Kuala Lumpur, Malaysia, 50603
        • Faculty of Dentistry Universiti Malaya

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Auto Tooth Graft
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
Kombinationsprodukt: auto tooth graft material
auto tooth graft (dentin graft) is taken from patient's extracted lower wisdom tooth. Ethoss is a synthetic material
Aktiv komparator: Ethoss
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
Kombinationsprodukt: auto tooth graft material
auto tooth graft (dentin graft) is taken from patient's extracted lower wisdom tooth. Ethoss is a synthetic material

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Periodontal health assessment on lower second molar
Tidsram: baseline on day of surgery, 12 weeks and 24 weeks after surgery
  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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bone gain
Tidsram: 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.
radiograph taken prior to surgery and 24 weeks after surgery

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain, swelling and mouth opening
Tidsram: 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)
Prior to surgery, 1 week and 4 weeks after the surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Malaya

Utredare

  • Huvudutredare: Chuey Chuan Tan, MClinDent (OMFS), Universiti Malaya, Malaysia
  • Studierektor: Wei Cheong Ngeow, Phd, University of Malaya

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2023

Primärt slutförande (Faktisk)

1 oktober 2025

Avslutad studie (Faktisk)

1 oktober 2025

Studieregistreringsdatum

Först inskickad

7 juli 2026

Först inskickad som uppfyllde QC-kriterierna

20 juli 2026

Första postat (Faktisk)

23 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • DF OS2316/0084 (P)
  • UMG027E-2023 (Annat bidrag/finansieringsnummer: Universiti Internal Grant (DPRG))

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy. The informed consent approved by the Ethics Committee/Institutional Review Board (IRB) did not include explicit authorization from participants for secondary data sharing or broad external repository deposition. Furthermore, due to the granular nature of the clinical data collected, full de-identification cannot be guaranteed without risk of re-identification. Aggregate data, summary statistics, and primary outcomes will instead be made available through peer-reviewed publications.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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