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)
20 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
12
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Wilayah Perseketuan Kuala Lumpur
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Kuala Lumpur, Wilayah Perseketuan Kuala Lumpur, Malaysia, 50603
- Faculty of Dentistry Universiti Malaya
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
auto tooth graft (dentin graft) is taken from patient's extracted lower wisdom tooth.
Ethoss is a synthetic material
|
|
Comparatore attivo: 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
|
auto tooth graft (dentin graft) is taken from patient's extracted lower wisdom tooth.
Ethoss is a synthetic material
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Periodontal assessment on lower second molar
Lasso di tempo: baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
The higher the score, the worse of the periodontal health condition |
baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Bone gain
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain, swelling and mouth opening
Lasso di tempo: 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
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Chuey Chuan Tan, MClinDent (OMFS), Universiti Malaya, Malaysia
- Direttore dello studio: Wei Cheong Ngeow, Phd, University of Malaya
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 agosto 2023
Completamento primario (Effettivo)
1 ottobre 2025
Completamento dello studio (Effettivo)
1 ottobre 2025
Date di iscrizione allo studio
Primo inviato
7 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
20 luglio 2026
Primo Inserito (Effettivo)
23 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- DF OS2316/0084 (P)
- UMG027E-2023 (Altro numero di sovvenzione/finanziamento: Universiti Internal Grant (DPRG))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
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