Clinical Evaluation of Effects of Adjunctive Use of Topical and Systemic Administration of Coenzyme Q10 in Non- Surgical Periodontal Therapy: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Clinical Attachment Level.
研究概览
简要总结
Title of the Research Proposal: CLINICAL EVALUATION OF EFFECTS OF ADJUNCTIVE USE OF TOPICAL AND SYSTEMIC ADMINISTRATION OF COENZYME Q10 IN NON- SURGICAL PERIODONTAL THERAPY: A RANDOMIZED CONTROLLED TRIAL.
Aim: To clinically evaluate and compare periodontal parameters like plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment levels over a follow-up period of 3 months, in a cohort of stage II periodontitis patients who have been randomized into three treatment groups; a group of participants who will receive non-surgical periodontal therapy (NSPT) consisting of scaling and root planing (SRP), Coenzyme Q10 (CoQ10) intrasulcular application, CoQ10 oral supplements and daily use of CoQ10.
Materials and methods: A cohort of 69 participants who are presenting with stage II periodontitis will be selected from the out-patients visiting the department and an informed consent will be administered. The participants will be randomized into three groups, For the participants allotted to Test Group 1: soon after completion of SRP, the pockets will be irrigated with normal saline such that there is no debris and any blood clots remaining in pockets. The pockets will be dried sufficiently using blunted absorbent paper points. CoQ10 gel will be aspirated into a disposable syringe and then the solution will be delivered intrasulcularly at those sites which are having PPD of more than or equal to 4mm and less than or equal to 5mm and CAL of 3-4 mm. The needle of the syringe will be placed parallel to the long axis of the tooth and gently inserted up to 1mm less than the depth of the pocket. The plunger will be pressed with delicate force such that the gel extrudes out of the syringe tip at the depth of pocket slowly. The syringe will be slowly withdrawn from the pocket as the plunger will be pushed and the gel will be flooding the pocket at where the needle tip will be located until it will be totally out of pocket confines. No force will be applied on the pocket externally. The participant will be asked not to rinse her/his mouth for a period of half hour thereafter. She/he will be told not to eat any food or drink any fluid for 2 hours after the intrasulcular application. The participant will be given 30 softgel capsules of CoQ10 and asked to take one softgel along with water soon after dinner, every day for next 30 days. Also, a tube of dentifrice containing CoQ10 will be handed over to the participants and they will be asked to use only that dentifrice and no other toothpaste for their daily twice a day oral hygiene routine for next 3 months. At the end of 1 month, she/he will be asked to report back to the clinic and after recording the timepoint ‘t1’ scores she/he will be handed a further 60 CoQ10 softgel capsules and 2 tubes of dentifrice containing CoQ10 for daily oral supplementation and twice-daily oral hygiene for next 60days. The participant will return for follow-up at timepoint ‘t3’, i.e. 3- months after intrasulcular application of CoQ10. For the participants allotted to Test Group 2: soon after completion of SRP, the pockets will be irrigated with normal saline so as to remove any debris/blood clots and then dried with absorbent paper points. CoQ10 gel will be delivered intrasulcularly in the same technique as in Test Group 1. No softgel capsules of CoQ10 will be given to these participants allotted to Test Group 2. Only the dentifrice containing CoQ10 will be given to these participants to be used in the same fashion as with Test Group 1. At the end of 1 month, the participant will be asked to report back to the clinic and after recording the timepoint ‘t1’ scores she/he will be handed a further 2 tubes of dentifrice containing CoQ10 twice-daily oral hygiene for next 60days. The participant will return for follow-up at timepoint ‘t3’, i.e. 3- months after intrasulcular application of CoQ10. For the participants allotted to Control Group: soon after completion of SRP, the pockets will be irrigated with normal saline so as to remove any debris. No CoQ10 intrasulcular application will be done. No softgel capsules nor any dentifrice containing CoQ10 will be given. A standard dentifrice tube not containing CoQ10 will be given to be used twice daily. The participants will be asked to return for follow-up after 30 days for checkup and recording of scores at time-point t1, and then again after 3-months from baseline for follow-up at time-point t3.
Data Analysis. The data will be analyses statistically with standard analysis of variance at a level of significance of p?0.05
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients diagnosed with stage II periodontitis
- •having more than two non-adjacent sites with probing pocket depth (PPD) of more than or equal to 4mm and less than or equal to 5mm and clinical attachment loss (CAL) of 3-4 mm
- •having at least 6 teeth in any arch, not including the third molar
- •systemically healthy Indian patient
- •ready to come for 3-month recall.
排除标准
- •presence of periapical or pulpal infections on qualifying teeth
- •requiring regular warfarin therapy
- •diagnosed with bile duct obstruction
- •prescribed chemotherapeutic drugs
- •taking any supplement of anti-oxidants for another condition
- •patients averse to taking medications that are not suitable to vegetarians
- •history of hypersensitivity to excipients that are present in CoQ10 dentifrice
- •history of sudden hypoglycaemic episodes
- •oral conditions requiring emergency treatment
- •lack of motivation and/or non-compliance to oral hygiene
- •moderate/heavy smoking or any other form of tobacco addiction
- •uncontrolled diabetes mellitus
- •pregnancy and lactation
- •chronic alcohol consumption
- •received scaling, root planing and polishing within 4 months prior to study
- •use of systemic or subgingival antimicrobials microbials within 6 months prior to baseline examination
- •ongoing drug therapy that could affect the clinical features of periodontitis or the response to periodontal treatment.
结局指标
主要结局
Clinical Attachment Level.
时间窗: 1.at baseline; | 2.at 4 weeks; | 3.at 12 weeks
次要结局
- Plaque Index, as described by Silness & Löe (1964)(1.at baseline;)
- Gingival index as described by Löe & Silness (1963)(1.at baseline;)
- Bleeding on probing (BOP) as described by Lang et al., (1990)(1.at baseline;)
- Probing Pocket Depth(1.at baseline;)
- Relative Attachment Level.(1.at baseline;)
研究者
Dr Anisha Rani
Uttaranchal Dental and Medical Research Institute