Melatonin Supports Non Surgical Periodontal Treatment in Patients With Type 2 Diabetes and Periodontitis

NCT05870358 | Completed Phase 4

• 1 other identifier: RecepTayyipErdoganU.2
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Background and aim: Hyperinflammatory host response associated with diabetes mellitus significantly provokes periodontal tissue destruction. In this context, supporting the standard treatment of periodontitis in diabetics with host modulation agents is a current field of study. This clinical study aims to investigate the clinical efficacy of melatonin supplementation in non-surgical periodontal treatment in patients with Type 2 DM and periodontitis and its biological basis (clinical effectiveness) based on some basic markers. Material and method: In this randomized controlled and double-blind study, 27 of 55 patients with diabetic periodontitis underwent full mouth scaling and root planning (fmSRP) alone and 28 of them were administered melatonin (6 mg daily, for 30 days) in addition to fmSRP. The possible therapeutic contribution of melatonin was evaluated clinically and biochemically \[gingival crevicular fluid (GCF) RANKL, OPG and MMP-8 and serum IL-1β levels\] at 3 and 6 months.

Conditions

Diabetes Mellitus; Periodontitis; Melatonin; Matrix Metalloproteinases

Outcome Measures

Primary Outcomes (10)

• Clinical Findings: Plaque index score(PI)

  According to the tooth Plaque index, each tooth surface was divided into 4 separate regions and the plaque intensity for each region is scored as: 0 = No plaque in the gingival area. 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface. Finally, scores are collected and calculate the arithmetic mean for the mouth score.

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Clinical Findings: Gingival index score (GI)

  The criteria are entirely confined to qualitative changes in the gingival soft tissue.Periodontal probe was used and gently inserted the sulcus. Each tooth surface was divided into 4 separate regions and the gingival bleeding activity for each region is scored as: 0 = Normal gingiva 1. = Mild inflammation -slight change in color, slight oedema. No bleeding on probing 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing 3. =Severe inflammation -marked redness and oedema. Ulceration. Tendency to spontaneous bleeding. Finally, scores are collected and calculate the arithmetic mean for the mouth score.

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Clinical Findings: Bleeding on probing(BOP)

  Each tooth surface was divided into 4 separate regions and gently probed by using periodontal probe.There is a bleeding as a positive score, and there is no bleeding as a negative score. The BOP is considered positive if bleeding occurred between 30 seconds after probing. Whole the probed area and positive score area ratio were calculated and BOP(%)score was found.

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Clinical Findings:Probing pocket depth (PPD)

  Probing pocket depth (PPD) measured with a periodontal probe on 6 different points around each tooth. PPD is known as distance between gingival margin and the base of the pocket/sulcus. By using periodontal probe(Williams periodontal probe) 6 different points are measured. Each scores of surfaces are collected and averaged for the mouth score for PPD.

  Change from baseline(T0) to 3rd month (T1) and 6th month (T2)

• Clinical Findings: Clinical Attachment Level (CAL)

  By using periodontal probe(Williams periodontal probe) 6 different points are measured.CAL, distance from the bottom of the pocket to the cemento-enamel junction of tooth. If there is gingival recession, recession depth is also added the CAL. By using periodontal probe(Williams periodontal probe) 6 different points are measured. Each scores of surfaces are collected and averaged for the mouth score for CAL.

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Biochemical Findings: RANKL (pg/ml)

  RANKL (pg/ml) were measured samples from gingival crevicular fluid by using commercial ELİSA kits according to the instructions of the kit manufacturer

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Biochemical Findings: OPG (pg/ml)

  OPG (pg/ml) were measured samples from gingival crevicular fluid by using commercial ELİSA kits according to the instructions of the kit manufacturer

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Biochemical Findings: MMP-8(ng/ml)

  MMP-8(ng/ml) were measured samples from gingival crevicular fluid by using commercial ELİSA kits according to the instructions of the kit manufacturer

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Biochemical Findings: IL-beta(pg/ml)

  IL-beta(pg/ml) were measured samples from serum by using commercial ELİSA kits according to the instructions of the kit manufacturer

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

• Biochemical Findings: RANKL/OPG

  RANKL/OPG, numeric ratio that can be indicated as only numeric value(no need some kind of units)

  Change from baseline(T0) to 3rd month(T1) and 6th month(T2)

Study Arms (2)

fmSRP

NO INTERVENTION

27 patients with diabetic periodontitis underwent full mouth scaling and root planning (fmSRP) alone

fmSRP-mel

ACTIVE COMPARATOR

28 patients with diabetic periodontitis were administered systemic melatonin tablets (6 mg daily, for 30 days) immediately after fmSRP.

Drug: Melatonin 3 MG

Interventions

Melatonin 3 MG DRUG

In this clinical trial, all patients that have both diabetes mellitus and periodontitis were performed full mouth scaling and root planning in order to start their periodontal treatments. Different from the control group, in fmSRP-mel group's patients systemic melatonin tablets (6 mg daily, for 30 days) were given immediately after the fmSRP procedure in order to support the scaling and root planning.

Also known as: Melatonina 3mg

fmSRP-mel

Eligibility Criteria

• Age: 31 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the WHO, in individuals in the young age category (18-65 years)
• Periodontitis diagnosed patients, "stage 3/4 periodontitis" was determined according to the current periodontal disease and condition classification as the diagnostic criterion for periodontitis
• Diabetic patients, our diagnostic criteria for Type 2 DM was fasting plasma glucose level greater than 126 mg/dl and glycosylated hemoglobin level (HbA1c) greater than 6.5%.

You may not qualify if:

• Smoke, use antibiotics, anti-inflammatory and antioxidant drugs in the last 6 months
• Work night shifts
• Pregnancy and lactation
• Cancer and autoimmune diseases
• Kidney disease
• Periodontal treatment in the last 6 months
• Obese patients (In Europe, obesity is defined as a body-mass index of more than 30 kg/m2 and a waist circumference of more than 88 cm in women and 102 cm in men)

Sponsors & Collaborators

• Yağmur Saraç Gül: lead

Study Sites (1)

Yagmur Sarac Gul

Rize, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Periodontitis

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: One of the principal investigator

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: May 23, 2023
• Study Start: February 18, 2021
• Primary Completion: January 18, 2022
• Study Completion: June 18, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)