A clinical evaluation of severity and management of peri-implantitis around dental implant in post COVID 19 patients- Randomized control trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Clinical evaluation of Peri-implant plaque index (PI), BOP, PPD, CAL.
研究概览
简要总结
AIM AND OBJECTIVE:
The objectives of the study are to compare and evaluate the following parameters at predetermined time intervals.
ï‚· To evaluate and compare the effect of two different treatment modalities on peri-implant soft tissues, marginal bone loss, healing, implant stability and overall survival rate.
ï‚· To evaluate aesthetic outcomes and oral hygiene maintenance.
ï‚· To evaluate bone biomarker (OPG) between the two groups.
ï‚· Patient compliance and experience.
PLACE OF STUDY:
Department of Prosthodontics and Crown & Bridge, Faculty of Dental Sciences, King George’s Medical University, Lucknow, India.
MATERIALS AND METHODS:
A randomized controlled clinical trial of 6 month follows up period is designed in which approx. Sixty individuals (30 in the test-group and 30 in the control-group) will be derived from prosthodontics department of King George’s Medical University, Lucknow (U.P). Patient will be considered eligible according to predefined inclusion and exclusion criteria. This study will be carried out for 2 years along with the follow up of the patients. Informed consent will be taken from each patient who will be participating in the study. Ethical clearance will be obtained from the ethical committee. Randomisation will be done using computer generated sequence of random numbers and allocation will be done using sealed envelopes.
The treatment in two groups will be given as under-
(a) Test group: patients underwent mechanical debridement with adjunct laser therapy; and
(b) Control group: patients underwent mechanical debridement with adjunct antimicrobial therapy.
ASSESMENT OF CRITERIA FOR EVALUATION: -
I) Clinical Parameter:
i. Periimplant plaque index (PI)
ii. Bleeding on probing (BOP)
iii. Probing pocket depth (PPD) by using plastic probe at six sites of implant (mesio, disto, midbuccal, mesio, disto, mid lingual/palatal).
iv. Clinical attachment loss (CAL)
II) Implant stability / mobility:
By resonance frequency test/ percussion test.
III) Radiographic parameter:
Peri-implant marginal bone levels/crestal bone loss (CBL) at follow ups.
IV) Aesthetic outcomes:
Pink esthetic score
White esthetic score
V) Healing and Pain at each follow up.
VI) Human Osteoprotegerin (OPG) ELISA test from Peri-implant sulcular fluid (PISF).
Statistical analysis-For the significant value of research data SPSS softwarewill be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Post covid-19 healthy subjects will be recruited who have SPO2, Pulse rate, Blood pressure within standard limits.
- •Ability to understand the procedure and provide informed consent assessed by decision making capacity and approaches before being included in the study.
- •Diagnosis of peri-implantitis based on the soft tissue around the implant showing obvious inflammatory symptoms, bone loss revealed by X-ray examination and probable haemorrhage and suppuration.
- •At least 2 implant site with periodontal PD ≥4- 6 mm.
- •Plaque Index around the implant ≥ 2 points Visible bleeding around the implant after probing.
- •CAL ≤ 3 mm.
排除标准
- •Current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or chewing tobacco.
- •History of drug abuse or alcoholism within the past 5 years Severe bruxism or clenching habit.
- •Significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
- •History of systemic disease that precludes standard dental implant therapy.
- •Past history of implant repair and failure over past 6 months.
结局指标
主要结局
1. Clinical evaluation of Peri-implant plaque index (PI), BOP, PPD, CAL.
时间窗: Upto 2 years
2. Radiographically evaluation of Marginal bone loss.
时间窗: Upto 2 years
3. Evaluation of OPG levels in Peri-implant sulcular fluid (PISF).
时间窗: Upto 2 years
次要结局
- 1. Evaluation of implant stability by Resonance frequency test.(2. Evaluation of pink and white aesthetic score.)
研究者
Mayank Singh
King Georges Medical University