Effectiveness of platelet concentrate in non surgical treatment of periodontitis

Phase 3

Not yet recruiting

Conditions: Chronic periodontitis,

Registration Number: CTRI/2022/04/042092

Lead Sponsor: State Board Of Medical Research

Brief Summary: Periodontal disease is the sixth most prevalent health condition that affects humans. It is one of the important reasons for tooth loss, impacts the quality of life of individuals. Emerging evidence links it to several systemic life threatening conditions like cardiovascular disease and diabetes making it an important public health problem. The objective of the prospective intervention trial is to assess the effectiveness of intrapocket delivery of injectable platelet rich fibrin in the non surgical management of moderate to severe periodontitis when compared to conventional scaling root planing. These autologous platelet concentrate are suspensions of growth factors and when applied locally ,they can induce soft and hard tissue regeneration. Since the standard PRF is not entirely appropriate for injection ,a new injectable formulation of PRF(termed i-PRF)enables easier use of platelet concentrate in liquid state. Otherwise healthy adults with moderate to severe periodontitis who satisfies the inclusion criteria are included in the study.Eligible individuals are randomized into test and control groups by split mouth design. Conclusions will be drawn based on the results. Treatment of periodontal disease is complicated and expensive. Many patients require invasive procedures including regenerative therapy. Adjunctive approaches to conventional non surgical therapy has page been investigated widely to avoid invasive surgical interventions. This study is such an attempt, where by an adjuvant like autologous platelet concentrate is added to conventional nonsurgical therapy in order to assess whether there is any improvement in clinical outcomes when compared to non surgical therapy alone. If found beneficial it would be highly encouraging for the resource poor Indian health system.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

(a) subjects with age more than 18 (b) systemically healthy subjects (c) Patients with at least two sites with probing pocket depth (PPD) â‰¥ 5 mm on contralateral side either in maxilla or mandible.

Exclusion Criteria

Subjects with habit of Smoking and tobacco chewing 3) Subjects taking Medications affecting the periodontium 4) Pregnancy or lactation 5) Subjects received probiotic or antimicrobial therapy in the past 6 months 6) Subjects underwent periodontal therapy in the past 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probing pocket depth	Final outcome assessed at 6th month after nonsurgical periodontal therapy

Secondary Outcome Measures

Name	Time	Method
1) clinical attatchment level	2) Gingival recession

Trial Locations

Locations (1): Government Dental College Kottayam
🇮🇳
Kottayam, KERALA, India
Government Dental College Kottayam
🇮🇳Kottayam, KERALA, India
Dr Baiju R M
Principal investigator
9447279605
baijurm@gmail.com