Comparison of Amfresh gel and Chlorhexidine gel as an adjunct to scaling and root planing in periodontitis patients.

Phase 2

Not yet recruiting

• Conditions: Chronic periodontitis, (2) ICD-10 Condition: Z515||Encounter for palliative care,

• Registration Number: CTRI/2021/11/038043
• Lead Sponsor: Dr Swapna Mahale

Brief Summary

There are various local drug delivery systems available, but since long, Chlorhexidine has been one of the most effective topical antimicrobial agent used. However there are  some inevitable side effects of chlorhexidine likebrown discoloration of teeth, some restorative materials and also dorsum of tongue , taste disturbances where the salty taste perception is particularly affected, oral mucosal erosion and unilateral or bilateral parotid swelling. Resveratrol has potent antioxidant, antitumor and anti-inflammatory effects that benefit the treatment of some diseases, such as cancer, diabetes, cardiovascular  disorders , degenerative diseases, autoimmune diseases and metabolic diseases. The combination of Resveratrol and  curcumin  have additive or possibly even synergistic effects with respect to host modulation.  Hence this study will analyze the efficacy of Resveratrol, Chitosan, Neem & Curcumin (Amfresh) gel and chlorhexidine gel as a local drug delivery in periodontal pocket in chronic periodontitis patients

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-22
• Last Update Posted: 2021-12-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 1.Patient diagnosed with Generalised periodontitis stage 2 grade 2 currently unstable with no risk factor 2.
• Patients with persistent pocket depth of minimum 4 -6 mm having minimum of 2-3 sites.
• Systemically healthy subjects.

Exclusion Criteria

• 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 Resveratrol, Chitosan, Neem & Curcumin (Amfresh) gel.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative Attachment Level (RAL)	Baseline, 1 month and 3 months.
Plaque index (PI) (Silness J, Lo¨e H. 1964)	Baseline, 1 month and 3 months.
Probing Pocket Depth (PPD)	Baseline, 1 month and 3 months.

Secondary Outcome Measures

Name	Time	Method
Gingival Index (GI) (Loe and Silness, 1963)	Sulcus Bleeding Index.(SBI)(Muhlemann H.R & Son,1971)

Trial Locations

Locations (1)

MGVs KBH Dental College and Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

MGVs KBH Dental College and Hospital

🇮🇳Nashik, MAHARASHTRA, India

Dr Swapna Mahale

Principal investigator

9422764080

drsamahale@gmail.com