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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mahmoud S Al Kady, Bachelor
- Telefonnummer: +201002500448
- E-mail: ma.alkady11@gmail.com
Studiesteder
-
-
Cairo Governorate
-
New Cairo, Cairo Governorate, Egypten
- Badr University in Cairo
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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). |
|
Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Attachment Level (CAL)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Probing Pocket Depth (PPD)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 8 weeks
|
Assessment of Patient satisfaction by Likert-scale questionnaire |
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Rasha Wagih, Ass. Prof., Badr University in Cairo
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BUC-IACUC-260715-195
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