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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Mahmoud S Al Kady, Bachelor
- 전화번호: +201002500448
- 이메일: ma.alkady11@gmail.com
연구 장소
-
-
Cairo Governorate
-
New Cairo, Cairo Governorate, 이집트
- Badr University in Cairo
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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). |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Attachment Level (CAL)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Probing Pocket Depth (PPD)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 8 weeks
|
Assessment of Patient satisfaction by Likert-scale questionnaire |
8 weeks
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Rasha Wagih, Ass. Prof., Badr University in Cairo
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- BUC-IACUC-260715-195
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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