Melatonin Supports Non Surgical Periodontal Treatment in Patients With Type 2 Diabetes and Periodontitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Clinical Findings: Bleeding on probing(BOP)
研究概览
简要总结
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.
详细描述
Ethical Approval This double-blind and randomized controlled clinical study was carried out on 55 patients with Type 2 DM and periodontitis who applied to the Periodontology Clinic of the Faculty of Dentistry of Recep Tayyip Erdoğan University between 2021/February and 2022/January and met the study criteria. Ethical approval was given by the Clinical Research Ethics Committee of the Faculty of Medicine of the same university within the framework of the Declaration of Helsinki (2008) (2022/03). The possible risks and benefits of the treatment to be applied to the participants were mentioned and their verbal and written consents were obtained.
Working Groups According to the WHO, in individuals in the young age category, "stage 3/4 periodontitis" was determined according to the current periodontal disease and condition classification as the diagnostic criterion for periodontitis. Accordingly, probing pocket depth (PPD) should be at least 6mm and bone loss should be at least 3mm. Our diagnostic criteria for Type 2 DM was fasting plasma glucose (FPG) level greater than 126 mg/dl and glycosylated hemoglobin level (HbA1c) greater than 6.5%. Those who smoke, use antibiotics, anti-inflammatory and antioxidant drugs in the last 6 months, work night shifts, are in pregnancy and lactation, have cancer and autoimmune diseases, have kidney disease, have received any periodontal treatment in the last 6 months obese patients were also excluded from the study. In Europe, obesity is defined as a body-mass index (BMI) of more than 30 kg/m2 and a waist circumference of more than 88 cm in women and 102 cm in men.
Treatment Protocol According to the above criteria, patients included in the study were randomly divided into control (fmSRP) and treatment [fmSRP-melatonin (fmSRP-mel)] groups by a computer program by an independent researcher (HA). The investigator (YSG), who provided the sample and conducted the clinical procedures, was blind to the study groups. fmSRP is the approach of completing supragingival and subgingival debridement procedures within 24 hours with periodontal curettes, scalers and ultrasonic instruments. Additional melatonin administration was made in the form of tablets containing 6mg of melatonin daily for 30 days from the day following the SRP. Patients were instructed to take the tablets just before bedtime. No additional application was made in the control group. Within the scope of the non-surgical periodontal treatment program, all patients were trained on brushing teeth with the modified bass technique and the use of appropriate interface cleaning tools. These trainings were repeated in the maintenance sessions. Participants were also instructed not to use any mouthwash.
Sample Collection and Clinical Periodontal Measurements Clinical periodontal measurements with gingival crevicular fluid(GCF) and serum samples were performed at baseline (T0) and at 3th (T1) and 6th months (T2) following fmSRP. In all three periods, sampling was done one day before clinical periodontal measurements.
GCF samples were taken from the interproximal regions of the two teeth with the most radiographic bone loss in each of the four quadrants in the morning. Initially, proper isolation was achieved by means of cotton rolls. The area was slightly dried for 10 seconds. Sterile paper strips (Periopaper, Proflow, Inc., Amityviile, NY) were advanced until minimal resistance was felt in the sulcus. Waited 30 seconds. Paper strips contaminated with blood or saliva were not included. The GCF volume in each paper strip was measured using the periotron device (Periotron 8010 Harco Electronics, Winnipeg, Canada) by electrical compedance method and recorded as µl. Immediately afterwards, 8 paper strips obtained from each patient were transferred to an eppendorf tube containing 250 µl of phosphate buffer solution. It was stored in a -80°C freezer (Thermo Fisher Scientific, Waltham, MA, USA) until the day of biochemical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 31 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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)
研究组 & 干预措施
fmSRP-mel
28 patients with diabetic periodontitis were administered systemic melatonin tablets (6 mg daily, for 30 days) immediately after fmSRP.
干预措施: Melatonin 3 MG (Drug)
结局指标
主要结局
Clinical Findings: Bleeding on probing(BOP)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
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.
Clinical Findings:Probing pocket depth (PPD)
时间窗: Change from baseline(T0) to 3rd month (T1) and 6th month (T2)
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.
Clinical Findings: Plaque index score(PI)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
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.
Clinical Findings: Gingival index score (GI)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
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.
Clinical Findings: Clinical Attachment Level (CAL)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
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.
Biochemical Findings: RANKL (pg/ml)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
RANKL (pg/ml) were measured samples from gingival crevicular fluid by using commercial ELİSA kits according to the instructions of the kit manufacturer
Biochemical Findings: OPG (pg/ml)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
OPG (pg/ml) were measured samples from gingival crevicular fluid by using commercial ELİSA kits according to the instructions of the kit manufacturer
Biochemical Findings: MMP-8(ng/ml)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
MMP-8(ng/ml) were measured samples from gingival crevicular fluid by using commercial ELİSA kits according to the instructions of the kit manufacturer
Biochemical Findings: IL-beta(pg/ml)
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
IL-beta(pg/ml) were measured samples from serum by using commercial ELİSA kits according to the instructions of the kit manufacturer
Biochemical Findings: RANKL/OPG
时间窗: Change from baseline(T0) to 3rd month(T1) and 6th month(T2)
RANKL/OPG, numeric ratio that can be indicated as only numeric value(no need some kind of units)
次要结局
未报告次要终点
研究者
Yağmur Saraç Gül
One of the principal investigator
Recep Tayyip Erdogan University