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)
2026年7月26日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
12
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Wilayah Perseketuan Kuala Lumpur
-
Kuala Lumpur、Wilayah Perseketuan Kuala Lumpur、マレーシア、50603
- Faculty of Dentistry Universiti Malaya
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Periodontal health assessment on lower second molar
時間枠：baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
|
baseline on day of surgery, 12 weeks and 24 weeks after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bone gain
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain, swelling and mouth opening
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Chuey Chuan Tan, MClinDent (OMFS)、Universiti Malaya, Malaysia
- スタディディレクター：Wei Cheong Ngeow, Phd、University of Malaya
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年8月1日
一次修了 (実際)
2025年10月1日
研究の完了 (実際)
2025年10月1日
試験登録日
最初に提出
2026年7月7日
QC基準を満たした最初の提出物
2026年7月20日
最初の投稿 (実際)
2026年7月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月28日
QC基準を満たした最後の更新が送信されました
2026年7月26日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- DF OS2316/0084 (P)
- UMG027E-2023 (その他の助成金/資金番号：Universiti Internal Grant (DPRG))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。