Effect of green coffee gel in treatment of periodontal pocket in chronic periodontitis patient

Phase 3

Not yet recruiting

Conditions: Chronic periodontitis,

Registration Number: CTRI/2020/07/026770

Lead Sponsor: MGVs KBH dental collage

Brief Summary: This study will be carried out in 45 patients with mild to moderate chronic periodontitis having minimum pocket depth of 5-7 mm in systemically healthy patients. Acrylic stent will be used to ensure reproducibility of measurements during the subsequent examinations of PPD, RAL. All the patients will be screened for periodontal findings. Patients meeting the inclusion criteria will be considered for the present study. Scaling and root planing will be done. Patient will be recalled after 3-4 weeks for rechecking of periodontal findings. Persistent pockets of minimum 4-6 mm will be considered for the further study. Selected patients will be randomly divided into 3 groups: Group A- subgingival application of green coffee gel (15 patients) Group B- subgingival application of chlorhexidine gel (15 patients) Group C- Scaling and root planing only (15 patients). In selected sites, subgingival plaque sample will be collected by a sterile curette and colony forming unit will be assessed. The experimental sites will be isolated with cotton rolls to prevent contamination from saliva. The green coffee or chlorhexidine gel will be delivered subgingivally in the periodontal pocket. The pocket opening will be covered with Coe-pak to retain the material in the pocket, as well as to prevent the ingress of oral fluid. Subjects will be recalled after 7 days for removal of the periodontal dressing. Reassessment of the clinical parameters will be done at 1 and 3 month and colony forming unit will be assessed after 3 months of placement of experimental drugs. In between these appointments the patients will ask to maintain the oral hygiene. No other chemical plaque control measures will be used during the trial period.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

1.Patient diagnosed with mild and moderate chronic periodontitis 2.
Patients with persistent pocket depth of minimum 4 -6 mm having minimum of 2-3 sites.
Systemically healthy subjectS.

Exclusion Criteria

1.History of any previous periodontal therapy in the last 6 months.
2.Use of drugs such as antibiotics, anti-inflammatory, corticosteroids,chemotherapeutics or immunological modulators that might alter the expected response of the oral tissues.
Tobacco consumption in any form.
Systemic diseases influencing the periodontal disease.
Pregnant and lactating women.
Allergy to chlorhexidine and green coffee.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Plaque Index (PI) (Silness & Loe, 1964)	baseline, and after 1 as well as 3 month after placement of gel
2.Gingival Index (GI) (Loe and Silness, 1963)	baseline, and after 1 as well as 3 month after placement of gel
3. Sulcus Bleeding Index.(SBI)( Muhlemann H.R & Son,1971)	baseline, and after 1 as well as 3 month after placement of gel
4.Probing Pocket Depth (PPD)	baseline, and after 1 as well as 3 month after placement of gel
5.Relative Attachment Level (RAL)	baseline, and after 1 as well as 3 month after placement of gel

Secondary Outcome Measures

Name	Time	Method
colony forming unit	At baseline and 3 month after placement of drug

Trial Locations

Locations (1): MGVs KBH dental collage
🇮🇳
Nashik, MAHARASHTRA, India
MGVs KBH dental collage
🇮🇳Nashik, MAHARASHTRA, India
Dr Ankita Ashok Katkurwar
Principal investigator
8975916733
katkurwarankita@gmail.com