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 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
12
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Wilayah Perseketuan Kuala Lumpur
-
Kuala Lumpur, Wilayah Perseketuan Kuala Lumpur, Malaisie, 50603
- Faculty of Dentistry Universiti Malaya
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Periodontal health assessment on lower second molar
Délai: baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
|
baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bone gain
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain, swelling and mouth opening
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Chuey Chuan Tan, MClinDent (OMFS), Universiti Malaya, Malaysia
- Directeur d'études: Wei Cheong Ngeow, Phd, University of Malaya
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2023
Achèvement primaire (Réel)
1 octobre 2025
Achèvement de l'étude (Réel)
1 octobre 2025
Dates d'inscription aux études
Première soumission
7 juillet 2026
Première soumission répondant aux critères de contrôle qualité
20 juillet 2026
Première publication (Réel)
23 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- DF OS2316/0084 (P)
- UMG027E-2023 (Autre subvention/numéro de financement: Universiti Internal Grant (DPRG))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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