Effects of Local Minocycline Adjunctive Application in Comparison to Instrumentation Alone, in Patients With Residual Pockets Under Supportive Periodontal Therapy: a Double-blinded Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Absolute change of probing pocket depth (PPD)
研究概览
简要总结
The aims of the present study are to assess the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of the medication that is detected at 3 months during a 9-month period of regular SPT. Recurrent periodontitis will be defined as sites with residual periodontal probing depths and bleeding on probing after completion of initial periodontal therapy. This will include both persistent and recurrent periodontitis, where persistent means the residual periodontal site after initial periodontal therapy, and recurrent means the site which was improved by initial periodontal therapy, but disease recurred.
详细描述
It has been reported that regular maintenance of subjects with treated periodontal disease is the key consideration in the long-term periodontal prognosis of these subjects. Periodic prophylaxis may prevent loss of clinical attachment over long periods of time even in patients with less than optimal plaque control. However, there are limitations in routine subgingival re-instrumentation especially in bleeding pockets, as only 50% of these sites improve. Furthermore, the persistence of bleeding pockets increases the risk of disease progression and tooth loss. Thus there is a need for adjuncts that may improve the outcome especially in subjects with recurrent periodontitis during SPT. Some studies reported significantly better results with subgingival administration of local minocycline in residual pockets post initial periodontal therapy over a short period of time. There are few studies assessing the efficacy of topical minocycline gel in subjects with recurrent periodontitis while in SPT, and the long term effect.
The present study will examine the significance of the adjunctive effect of the subgingival application of a 2% minocycline hydrochloride controlled-delivery system (MHS) in comparison to subgingival instrumentation with application of a placebo gel, 3 months after therapy in subjects with recurrent periodontitis undergoing supportive periodontal therapy (SPT) and to assess the substantivity of the gel attributable to the adjunctive delivery of the medication that will be detected at 3 months during a 9-month period of regular SPT.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The examiners (PI and Outcomes Assessors) will be blinded during the clinical examination of the patients. The topical antibiotic will be administered by a trained and delegated clinician who is not involved in the outcome assessment.
Patients will be blinded to their treatment group as well.
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically healthy adults (ASA classification I-II)
- •At least 21 years of age.
- •Previously diagnosed with moderate to severe periodontitis and had completed at least 1 round of periodontal therapy including scaling and root-planing, oral hygiene instructions.
- •Treated periodontitis patients undergoing maintenance care for at least 6 months.
- •Ability to comply with 12-month study follow-up.
- •Recurrent moderate to severe periodontitis with no previous systemic antibiotic therapy during initial periodontal therapy.
- •At least 4 teeth present with residual PPD of ≥ 5 mm on each and a positive bleeding on probing (BOP).
排除标准
- •Medically compromised subjects (ASA classification III-V).
- •Known allergy or other severe adverse reactions to minocycline and related drugs.
- •Patients who reported local and/or systemic antibiotic therapy within 3 months prior to baseline examination of the study, and were placed on antibiotics during active initial periodontal therapy.
- •Patients with a plaque control record > 30%.
- •Patients who had history of surgical periodontal treatment less than 5 years in the area with lesions.
- •Pregnant or intend to conceive or are breast feeding.
研究组 & 干预措施
2% minocycline hydrochloride controlled-delivery system (MHS)
Mechanical ultrasonic/ hand instrumentation and subsequent administration of MHS on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months
干预措施: 2% minocycline hydrochloride controlled-delivery system (MHS) (Drug)
Placebo
Mechanical ultrasonic/ hand instrumentation and subsequent administration of a placebo gel on that day (Day 0) and on Day 4, at 3 months, 6 months and 9 months
干预措施: Placebos (Drug)
结局指标
主要结局
Absolute change of probing pocket depth (PPD)
时间窗: 3 months
Absolute change of PPD at 3 months compared to baseline is defined as the difference between absolute patient PPD at 3 months and absolute patient PPD at baseline. For patients who have multiple trial sites, the mean of site absolute PPD will be used as their patient PPD score.
次要结局
- Incidence of recurrent rate during experimental period.(3, 6, 9,12 months)
- Absolute change of probing pocket depth (PPD)(6, 9,12 months)
- Percentage reduction of number of probing pocket depth (PPD) ≥ 5 mm(3, 6, 9,12 months)
- Reduction in bleeding on probing (BOP)(3 months vs baseline, 6 months vs baseline, 9 months vs baseline, 12 months vs baseline, 3 months vs 6 months, 3 months vs 6 months, 3 months vs 9 months, and 3 months vs 12 months.)
- Change of probing attachment level (PAL)(3, 6, 9,12 months)
研究者
Tan Wah Ching
Visiting Consultant
National Dental Centre, Singapore