The Effect of Different Types of Mouthwash on Extraction Sockets' Healing
2026年5月3日 更新者：Ahmad Abdel-Salam Hamdan、University of Jordan
A Randomized Controlled Trial on the Effect of Different Types of Mouthwash on the Healing of Extraction Sockets
The goal of this clinical trial is to assess the effect of four different types of mouthwash on socket healing after surgical extractions in male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar indicated for extraction. The main questions it aims to answer are:
The effect of Bone Bioactive Liquid (BBL) mouthwash, Hyaluronic Acid (HA) mouthwash, the Chlorhexidine digluconate (CHX) mouthwash and Warm Saline Mouth Rinse (WSMR) on socket healing after surgical extractions.
The effect of BBL mouthwash, HA mouthwash, the CHX mouthwash and WSMR on patient related factors and their quality of life.
Recruited Participants will be randomized into four intervention groups:
- First group will receive BBL mouthwash.
- The second group will receive CHX mouthwash.
- The third group will be prescribed HA mouthwash.
- The fourth group will receive Warm Saline Mouth Rinse.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
100
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。
研究連絡先
- 名前：Ahmad Hamdan, Ph.D. in Periodontics
- 電話番号：+ 962779099199
- メール：Ahmad.hamdan@ju.edu.jo
研究場所
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Amman、ヨルダン、11941
- 募集
- University of Jordan hospital
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コンタクト：
- Ahmad Hamdan, Ph.D. in Periodontics
- 電話番号：+ 962779099199
- メール：Ahmad.hamdan@ju.edu.jo
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-
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
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Male or female patients aged 18 years and older who have a unilateral impacted mandibular third molar that is indicated for extraction with bone removal and the presence of an adjacent second molar.
Exclusion Criteria:
- Soft tissue impaction that will not need any bone removal.
- Presence of any acute oral infection including active Pericoronitis.
- Patients who have undergone radiotherapy in the head and neck region, chemotherapy or systemic long-term corticosteroid treatment.
- Patients receiving medications known to induce gingival hyperplasia; anticonvulsant (phenytoin), immunosuppressant (cyclosporine A), and various calcium channel blockers (nifedipine, verapamil, diltiazem).
- Patients who have taken systemic antibiotics less than 3 months prior to baseline.
- Presence of uncontrolled diabetes, severe nutritional deficiencies and endocrine disturbances.
- Presence of immune deficiency or any immune disease.
- Intravenous bisphosphonates or Oral bisphosphonate intake for more than 3 years.
- Smokers and alcoholics.
- Pregnant or lactating females.
- Hypersensitivity to one of the ingredients listed in any of the mouthwashes, especially chlorhexidine as reactions to this has been reported in the literature.
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Bone Bioactive Liquid
Bone bioactive liquid (BBL) is a saline solution used as a mouthwash that contains calcium chloride (CaCl2) and magnesium dichloride hexahydrate (MgCl2-6H2O) with a net negative charge.
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Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
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アクティブコンパレータ：Chlorhexidine Gluconate
It is a strong bisbiguanide base, with cationic structure at physiological pH (positively charged), and has a broad-spectrum antibacterial activity that works against Gram-positive and Gram- negative bacteria and certain mycetes.
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Prescribed for 7 days period 2 times a day starting 24 hours post-extraction, the patient is instructed to pour 10 ml of the mouthwash into a measuring cup, rinse for 1 minute at an alternative time to teeth brushing.
Do not eat or drink for 30 min after use.
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アクティブコンパレータ：Warm Saline Mouth Rinse
Prescribing WSMR as a prophylactic postoperatively is due to the fact that the heat of the solution results in a therapeutic increase in blood flow to the extraction socket.
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Prescribed for 7 days period 2 times a day starting 24 hours post-extraction.
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アクティブコンパレータ：Hyaluronic Acid mouthwash
It is a high molecular weight non-sulphated polysaccharide.
It is biocompatible, non-immunogenic, biodegradable, viscoelastic that make it a preferable biomaterial for medical and pharmaceutical applications without adverse events.
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Prescribed for 7 days period 3-4 times a day starting 24 hours post-extraction, the patient is instructed to pour 20 ml of the mouthwash into a measuring cup and rinse for 1 minute, at an alternative time to teeth brushing.
Do not eat or drink for 30 mins after use.
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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 |
|---|---|---|
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Extraction socket soft tissue healing
時間枠：Measured at 3, 7, 14 days, 3 and 6 months postoperatively.
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Using a new socket wound healing scale that is a combination of the gingival healing index of Landry et al. and the wound healing scale used by Cervelli et al. to assess the post-extraction wounds in terms of wound dehiscence, epithelialization, quality of granulation tissue filling the post-extraction socket, and depth between early granulation tissue and wound margin. A blunt periodontal probe with millimetric markers will be used for this assessment to score a number between 0 (best) and 4 (worst) for the healing socket. |
Measured at 3, 7, 14 days, 3 and 6 months postoperatively.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Extraction socket Bone healing
時間枠：Radiographs will be taken at baseline and at 6 months after extraction.
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Using panoramic radiographs and following the Longitudinal radiographic assessment (LRA) technique categorized as: A. The empty socket is completely radiolucent, and lamina dura is observed clearly around the socket.
B. Socket region is hazy and lamina dura is observed around the socket.
C.
There is a mixed radiolucent-radiopaque appearance inside the socket and lamina dura has been partially disappeared.
D. Mature bone is seen inside the socket and lamina dura has disappeared completely (no difference between the socket and normal bone).
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Radiographs will be taken at baseline and at 6 months after extraction.
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The resulting periodontal defect of the adjacent second molar
時間枠：Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Will be evaluated using a UNC 15 perio probe with three clinical parameters: the first is probing depth (PD) measured in mm at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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The resulting periodontal defect of the adjacent second molar
時間枠：Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Will be evaluated using a UNC 15 perio probe with three clinical parameters: the second is gingival recession (GR) measured in mm at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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The resulting periodontal defect of the adjacent second molar
時間枠：Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Will be evaluated using a UNC 15 perio probe with three clinical parameters: the third is bleeding on probing (BOP) measured as present or not at three sites of the second molar tooth: Distal (D), disto-buccal (DB), and disto-lingual (DL).
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively, we may call the patients for further assessment at 9 and 12 months
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Quality of life of the patients (QOL) after extraction
時間枠：At 3, 7, 14 days, 3 and 6 months postoperatively.
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Assessed based on a questionnaire that addresses different aspects including social and work isolation, ability to eat and speak, impairment of sleep schedule, their physical appearance related to swelling, bleeding and Paresthesia.
Answers to the presented questions are in the form of a four-point scale regarding their experience at the time the participants given the form to fill.
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At 3, 7, 14 days, 3 and 6 months postoperatively.
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Pain at the extraction side
時間枠：At 3, 7, 14 days, 3 and 6 months postoperatively.
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Assessed using a 10cm long visual analog scale (VAS) where 0= no pain and 10= maximum amount of pain.
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At 3, 7, 14 days, 3 and 6 months postoperatively.
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Trismus
時間枠：Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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By measuring the interincisal distance at the maximum mouth opening pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively, then the difference between pre- and postoperative will be taken.
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Pre-operatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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Facial swelling at the extraction side
時間枠：Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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Assessed using a soft tape to measure the distance between the lowest point of the tragus and the soft tissue pogonion, the lowest point of the tragus and the lateral corner of the mouth, the lateral corner of the eye and the angle of the mandible.
These measurements will be taken preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
Then the difference between the pre-operative and postoperative values will be divided by the value obtained in the preoperative period and multiplied by 100 to have the final percentage for the post-operative day.
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Preoperatively and at 3, 7, 14 days, 3 and 6 months postoperatively.
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Socio-demographic factors and medical history
時間枠：Once preoperatively.
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Data taken from participants using a form.
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Once preoperatively.
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Peri-operative factors
時間枠：During the surgical procedure.
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Operation time (min) categorized as <=20, >20 to 30, >30 to 40, >40.
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During the surgical procedure.
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Peri-operative factors
時間枠：During the surgical procedure.
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Amount of anesthesia administered.
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During the surgical procedure.
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Peri-operative factors
時間枠：During the surgical procedure.
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Tooth sectioning (done, not done).
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During the surgical procedure.
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Peri-operative factors
時間枠：During the surgical procedure.
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The surgeon's perception of difficulty categorized as <=9, >9 to 12, >12 to 16, >16.
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During the surgical procedure.
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Pre-operative factors
時間枠：Once preoperatively.
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The radiographic anatomical relationship between the tooth roots and mandibular canal as it appears on the radiographic image taken preoperatively, categorized as: No association between root structure and the superior border of the canal, Root structure impinging the superior border of canal, Overlapping root structure and canal.
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Once preoperatively.
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Pre-operative factors
時間枠：Once preoperatively.
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Prior symptoms related to the third molar to be extracted categorized as: present, absent.
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Once preoperatively.
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Pre-operative factors
時間枠：Once preoperatively.
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Indication for the surgical extraction of the third molar categorized as: prophylactic extraction, pain related to the third molar, orthodontic indication.
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Once preoperatively.
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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：Ahmad Hamdan, Ph.D. in Periodontics、Faculty of Dentistry - University of Jordan
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
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- Osunde OD, Adebola RA, Adeoye JB, Bassey GO. Comparative study of the effect of warm saline mouth rinse on complications after dental extractions. Int J Oral Maxillofac Surg. 2014 May;43(5):649-53. doi: 10.1016/j.ijom.2013.09.016. Epub 2013 Dec 5.
- Adekunle AA, Egbunah UP, Erinoso OA, Adeyemo WL. Effectiveness of warm saline mouth bath in preventing alveolar osteitis: A systematic review and meta-analysis. J Craniomaxillofac Surg. 2021 Oct;49(10):980-988. doi: 10.1016/j.jcms.2021.09.001. Epub 2021 Sep 4.
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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)
2025年8月10日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2026年12月1日
試験登録日
最初に提出
2024年8月31日
QC基準を満たした最初の提出物
2024年9月4日
最初の投稿 (実際)
2024年9月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月7日
QC基準を満たした最後の更新が送信されました
2026年5月3日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 224000195
- 284/2023-2024 (その他の助成金/資金番号：University of Jordan)
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?
はい
IPD プランの説明
The plan is to share only IPD used in the results publication
IPD 共有時間枠
Beginning from publication with no end date
IPD 共有アクセス基準
The principal investigator will review requests for IPD sharing according to the predetermined set of criteria.
The criteria that must be met in order for data to be shared are: having a study protocol that has been approved by an independent review committee identified for IPD meta-analyses.
The study protocol must be submitted through email then when reviewed data requestors will need to sign a data access agreement.
The data requestor will be provided with the IPD file that can be accessed by them only by having their email listed as a viewer in the sharing list of a folder stored on the DropBox website, this folder has the data excel sheet file and the study protocol as the supporting material.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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。