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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mahmoud S Al Kady, Bachelor
- Numéro de téléphone: +201002500448
- E-mail: ma.alkady11@gmail.com
Lieux d'étude
-
-
Cairo Governorate
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New Cairo, Cairo Governorate, Egypte
- Badr University in Cairo
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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). |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Attachment Level (CAL)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Probing Pocket Depth (PPD)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 8 weeks
|
Assessment of Patient satisfaction by Likert-scale questionnaire |
8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rasha Wagih, Ass. Prof., Badr University in Cairo
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BUC-IACUC-260715-195
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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