Effect of the Application of Chlorhexidine in the Pillars of Implant Healing to Prevent Plate Accumulation. Controlled Random Blind Clinical Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Degree of inflammation
研究概览
简要总结
The work hyposesis is based on the application of a chlorhexidine gel against the non-application on the healing abutments in patients who have received a submerged titanium implant to check its effect on healing and prevention of bacterial plaque accumulation during a period of 1 month.
详细描述
Once the implants are integrated, and given the consent, the patients will be operated to connect the healing abutments as they come from the manufacturer (Mozo Grau, Ticare®). Patients will follow the study protocol in 2 arms.
The random distribution is made prior to assignment following the internet program https://www.random.org
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double blindness performed for patients and for statistical analysis
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good systemic health status (ASA I or II).
- •No current pain.
- •No use of painkillers or Anti-inflammatory drugs in the prior weeks.
- •Older than 18 years.
- •Oral hygiene index of ≤ 2 (Löe and Silness).
- •A minimum of 2 mm of adhered gum.
- •A minimum of 8 mm of vertical bone.
- •A minimum of 7 mm of vestibule-lingual bone.
- •Scheduled to receive a unitary implant.
- •Willing to participate in this controlled study.
排除标准
- •Pregnant or nursing women.
- •Use of any type of medication that might affect the perception of pain.
- •An history of alcohol or drug abuse.
- •A requirement for guided regeneration or sinus lifting procedures.
- •Failure to comply with the study protocol.
研究组 & 干预措施
Placebo
The healing abutments were covered without any antiseptic gel after the first week of the second surgery (2-stage implants).
干预措施: Placebo (Other)
Test (clorhexidine gel)
The healing abutments were covered by a chlorhexidine gel after the first week of the second surgery (2-stage implants).
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Degree of inflammation
时间窗: 1 month after second surgery
Degree of inflammation was measured using a 4-point Likert scaleInflammation 0 = non-inflamed gingiva with pale pink color. Inflammation 1 = erythematous gingiva without bleeding on manipulation. Inflammation 2 = gingiva with slight bleeding during manipulation during unscrewing or screwing of the abutment. Inflammation 3 = gingiva with heavy bleeding during manipulation during unscrewing or screwing of the abutment.
次要结局
未报告次要终点
研究者
Arturo Sánchez-Pérez
Associate professor
Universidad de Murcia