Effects of Adjunctive Melatonin Gel in Type II Diabetics With Stage III-IV Periodontitis (MINST)
Effects of Adjunctive Melatonin Gel With Minimally Invasive Non-Surgical Therapy on Clinical Outcomes, Inflammatory Biomarkers and Glycemic Control in Type II Diabetics With Stage III-IV Periodontitis: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn if melatonin gel works to treat deep periodontal pockets in diabetic patients with periodontisits.
The main question it aims to answer is:
Does melatonin gel when used with minimal invasive non surgical periodontal therapy show better healing effects.
調査の概要
状態
詳細な説明
The goal of this clinical trial is to evaluate the effects of adjunctive locally delivered Melatonin gel combined with minimally invasive non-surgical therapy (MINST), compared with MINST alone, on clinical periodontal parameters, serum glycemic levels, and gingival crevicular fluid levels of Galectin-3 and interleukin-1β in patients with Stage III/IV periodontitis and type 2 diabetes mellitus.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mahmoud S Al Kady, Bachelor
- 電話番号：+201002500448
- メール：ma.alkady11@gmail.com
研究場所
-
-
Cairo Governorate
-
New Cairo、Cairo Governorate、エジプト
- Badr University in Cairo
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male and female participants. Patients diagnosed with Stage III / IV periodontitis. Presence of at least one site with probing pocket depth (PPD) ≥ 5 mm and clinical attachment loss consistent with Stage III/ IV periodontitis.
Subjects with glycated hemoglobin higher than 6.5% were defined as diabetic.
Exclusion Criteria:
- Smokers: current or former, as smoking impairs periodontal healing capacity and response to periodontal treatments.
Pregnancy and lactation due to ethical considerations and potential hormonal influences on periodontal tissues.
Patient who received periodontal therapy within the previous 6 months. Use of antibiotics, anti-inflammatory drugs, or antioxidant supplement within the previous 6 months.
Patient with systemic condition other than type 2 diabetes or medication that may affect periodontal healing.
研究計画
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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：MINST + Melatonin Gel
Participants will receive minimally invasive non-surgical periodontal therapy (MINST), followed by adjunctive subgingival application of 5% melatonin gel into selected periodontal pockets using a syringe equipped with a suitable cannula, once weekly for four consecutive weeks. |
Minimally invasive non-surgical periodontal therapy involving subgingival instrumentation using appropriate periodontal instruments under magnification loupes, with the aim of preserving soft tissue integrity and minimizing treatment trauma. Locally delivered 5% melatonin gel administered by subgingival application into selected periodontal pockets using a syringe equipped with a suitable cannula, The gel will be applied once weekly for four consecutive weeks as an adjunct to minimally invasive non-surgical periodontal therapy (MINST). |
|
アクティブコンパレータ：MINST Alone
Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone, without adjunctive melatonin gel. |
Minimally invasive non-surgical periodontal therapy involving subgingival instrumentation using appropriate periodontal instruments under magnification loupes, with the aim of preserving soft tissue integrity and minimizing treatment trauma. |
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 |
|---|---|---|
|
Clinical Attachment Level (CAL)
時間枠：from enrollment to 4 weeks then to the end of the study at 8 weeks
|
Change in clinical attachment level (CAL) from baseline to follow-up (measured in mm) following minimally invasive non-surgical periodontal therapy (MINST) with or without adjunctive local application of 5% melatonin gel. |
from enrollment to 4 weeks then to the end of the study at 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Probing Pocket Depth (PPD)
時間枠：from enrollment to 4 weeks then to the end of the study at 8 weeks
|
Change in probing pocket depth from baseline to follow-up (measured in mm) |
from enrollment to 4 weeks then to the end of the study at 8 weeks
|
|
Full mouth plaque score (FMPS)
時間枠：from enrollment to 4 weeks then to the end of the study at 8 weeks
|
Percentage of the sites of plaque |
from enrollment to 4 weeks then to the end of the study at 8 weeks
|
|
Full mouth bleeding score (FMBS)
時間枠：from enrollment to 4 weeks then to the end of the study at 8 weeks
|
Percentage of the sites of bleeding |
from enrollment to 4 weeks then to the end of the study at 8 weeks
|
|
GCF Galectin-3
時間枠：from enrollment to 4 weeks then to the end of the study at 8 weeks
|
Change in Gingival crevicular fluid level of human galactic-3 |
from enrollment to 4 weeks then to the end of the study at 8 weeks
|
|
GCF Interleukin 1
時間枠：from enrollment to 4 weeks then to the end of the study at 8 weeks
|
Change in Gingival crevicular fluid level of human interleukin 1 |
from enrollment to 4 weeks then to the end of the study at 8 weeks
|
|
Serum glycemic level
時間枠：from enrollment to the end of the study at 8 weeks
|
Assessment of patient's level of glycemic control measured by hba1c test |
from enrollment to the end of the study at 8 weeks
|
|
Patient satisfaction
時間枠：8 weeks
|
Assessment of Patient satisfaction by Likert-scale questionnaire |
8 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Rasha Wagih, Ass. Prof.、Badr University in Cairo
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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