The Influence of The Topical Combined Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate on Implant Osseointegration: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Implant Stability Measured by Implant Stability Quotient (ISQ) Using Resonance Frequency Analysis (RFA)
研究概览
简要总结
The goal of this clinical trial was to evaluate whether the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate could enhance implant osseointegration in adult dental implant patients. The main question it aimed to answer was:
Did the combined topical use of these agents improve implant stability during the healing phase?
Researchers compared intervention implants (which received the topical agents at the implant site) to control implants (which received standard placement without topical application) within the same participant, in order to assess differences in implant stability and osseointegration.
Participants:
Underwent dental implant surgery.
Received both the topical treatment and the standard procedure, applied to different implant sites.
Returned for follow-up visits, where implant stability was measured using resonance frequency analysis (RFA) at predefined time intervals.
详细描述
This randomized clinical trial was conducted to investigate the effect of the topical application of a combination of dexamethasone, ascorbic acid, and β-sodium glycerophosphate on the osseointegration of dental implants. The rationale behind the study was based on existing evidence suggesting that these agents may enhance bone healing, reduce inflammation, and support mineralization when applied locally.
Each participant received two dental implants: one designated as the intervention site (treated with the topical combination of the three agents at the time of implant placement), and the other as the control site (placed without any topical application). This split-mouth design allowed intra-individual comparison, minimizing the influence of patient-related variability.
Implant stability was assessed using resonance frequency analysis (RFA) at four follow-up intervals to evaluate differences in osseointegration between the two sites. The study aimed to determine whether the adjunctive use of these agents could improve early implant stability, potentially contributing to more predictable outcomes in dental implantology.
No investigational drugs or devices were used beyond standard clinical tools. The study was approved by a local ethics committee, and informed consent was obtained from all participants prior to enrollment.
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
This was a single-blind study in which participants were unaware of which implant site received the topical intervention. The care provider and investigator were aware of the allocation. Outcome assessors were masked to the assignment to ensure unbiased evaluation of implant stability measurements.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided a written informed consent prior to initiation of any study procedures.
- •Was able to understand and agrees to comply with planned study procedures and be available for all study visits.
- •Agreed to undergo cone beam computed tomography (CBCT) imaging.
- •Was a male or non-pregnant female, >/= to 18 years of age at the time of enrollment.
- •Was in good general health, free medical diseases.
- •Had two hopeless teeth for minimum required extraction for the purpose of implant-supported restorations.
排除标准
- •Was undergoing chronic treatment with any medication known to affect oral status and bone turnover.
- •Had a contraindication for surgical treatment.
- •Was suffering from a known psychological disorder.
研究组 & 干预措施
Intervention (Test)
Participants received a dental implant with the topical application of dexamethasone, ascorbic acid, and β-sodium glycerophosphate during surgery.
干预措施: Topical Application of Dexamethasone, Ascorbic Acid, and β-Sodium Glycerophosphate (Drug)
结局指标
主要结局
Change in Implant Stability Measured by Implant Stability Quotient (ISQ) Using Resonance Frequency Analysis (RFA)
时间窗: At baseline (day of surgery), 4 weeks, 8 weeks, and 16 weeks post-surgery
Implant stability will be assessed using resonance frequency analysis (RFA), with results reported as Implant Stability Quotient (ISQ) values. The ISQ scale ranges from 1 (lowest stability) to 100 (highest stability). Higher ISQ values indicate better implant stability and osseointegration.
次要结局
未报告次要终点
研究者
Manar Ziad Foura-Matar
Dentist ( Implantologist)
Al-Azhar University - Gaza