Effects of Adjunctive Melatonin Gel in Type II Diabetics With Stage III-IV Periodontitis
Periodontitis · Diabete Mellitus
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 32 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
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.
Procedure: Minimally Invasive Non-Surgical Periodontal Therapy (MINST) · Procedure: 5% Melatonin Gel
MINST Alone
Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone, without adjunctive melatonin gel.
Procedure: Minimally Invasive Non-Surgical Periodontal Therapy (MINST)
Minimally Invasive Non-Surgical Periodontal Therapy (MINST) PROCEDURE
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.
5% Melatonin Gel PROCEDURE
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).
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Clinical Attachment Level (CAL)
Plazo: 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.
Medidas secundarias
Probing Pocket Depth (PPD)
Plazo: 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)
Full mouth plaque score (FMPS)
Plazo: from enrollment to 4 weeks then to the end of the study at 8 weeks
Percentage of the sites of plaque
Full mouth bleeding score (FMBS)
Plazo: from enrollment to 4 weeks then to the end of the study at 8 weeks
Percentage of the sites of bleeding
GCF Galectin-3
Plazo: 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
GCF Interleukin 1
Plazo: 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
Serum glycemic level
Plazo: from enrollment to the end of the study at 8 weeks
Assessment of patient's level of glycemic control measured by hba1c test
Patient satisfaction
Plazo: 8 weeks
Assessment of Patient satisfaction by Likert-scale questionnaire
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Badr University in CairoNew Cairo, Cairo Governorate, EgyptEstado desconocido
Equipo y fechas
- Patrocinador principal
- Badr University
- Inicio del estudio
- 2026-11 Estimado
- Finalización primaria
- 2027-03 Estimado
- Finalización del estudio
- 2027-04 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
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
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026