Clinical and radiographic evaluation of periodontal bony defect fill with and without ascorbic acid admixed nanohydroxyapatite bone graft.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Periodontal probing depths(PD)
研究概览
简要总结
AIM: The aim of the present study is to evaluate clinical and Radiographic evaluation of periodontal bony defects with and without Ascorbic acid admixed nano hydroxyappatite bone grafts
All the participants will be explained about the aim, nature and design of the study along with a written informed consent for their participation before the commencement of the study.
The study is planned as a randomized clinical trial conducted in healthy individuals with Periodontitis. the study duration is 9 months in which clinical parameters will be recorded at baseline, 1 month and 6 months. Radiographic parameters will be recorded at baseline, 1 month, 6 months and 9 months.
The study will be performed in accordance with the Helsinki Declaration of 1975, as revised in 2013.
The clinical parameters for assessment include
-
Periodontal Probing Depth
-
Clinical Attachment Levels.
-
Gingival Bleeding Index
The radiographic parameters for assessment include
-
amount of bone fill
-
percentage of bone fill
All the patients included in this study will be evaluated before the treatment procedure and patients with periodontal bony defects will be selected.
Two sites left and right halves of the maxillary or mandibular rch will be selected and assigned as test and control groups.
Test group: Ascorbic acid admixed nano hydroxyapatite bone graft
Control group: hydroxyapatitie graft
Procedure: a split mouth design will be followed, where the bilateral quadrants with bony defects will be chosen. 30 sites from 15 patients will be selected and grouped as test and control site.
Clinical parameters will be recorded at baseline, 1 month, and 6 months, radiographic parameters will be recorded at baseline, 1 month, 6 months and 9 months in both the test and control groups.
Open flap debridement will be performed to all patients and nano hydroxyapatite bone graft will be placed in control site and ascorbic acid admixed nano hydroxyapatite bone graft will be placed in test sites.
Post operative instructions will be given to all the patients and will be recalled after 1 week for suture removal.
In any case of discomfort, patients are advised to report back
All the patients will be recalled again after 1 month, 6 & 9 months for re-evaluation of clinical and radiographic parameters in both test and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 48.00 Year(s)（—）
- 性别
- All
入选标准
- •Who are systemically healthy Both males and females with age ≥30 years having periodontitis with bilateral bony defects.
- •Pocket depths ≥5 mm after phase 1 evaluation.
- •Radiographic evidence of bone loss.
- •Participants who are co‑operative and able to come for regular follow-up.
- •Participants with ≥20 remaining teeth.
排除标准
- •Pregnant/lactating women Individuals who are known allergic to ascorbic acid.
- •Who received antibiotic therapy in the previous 6 months Who underwent periodontal therapy in the past 6 months Use of tobacco in any form Medically compromised or under therapeutic regimen that may alter the probability of periodontal healing.
结局指标
主要结局
Periodontal probing depths(PD)
时间窗: baseline,one month,6 months & 9 months
Clinical attachment levels(CAL)
时间窗: baseline,one month,6 months & 9 months
amount of bone fill
时间窗: baseline,one month,6 months & 9 months
Amount of bone fill
时间窗: baseline,one month,6 months & 9 months
次要结局
- Gingival Bleeding Index(Percentage Of Bonefill)