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Clinical Trials/CTRI/2024/09/074027
CTRI/2024/09/074027
Not yet recruiting
Phase 2/3

Comparative Evaluation of Efficacy of Herbal Mouthwash (Oralife) with Chlorhexidine Mouthwash (Rexidine SRS) in Generalized Chronic Periodontitis Patients- A Randomized Clinical Trial

Dr Aishwary Patil1 site in 1 country62 target enrollmentStarted: November 10, 2024Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Dr Aishwary Patil
Enrollment
62
Locations
1
Primary Endpoint
1. Plaque Index (P.I.) (Silness and Loe, 1964)

Overview

Brief Summary

Aim-To clinically compare and evaluate the efficacy of herbal mouthwash (OralifeTM) with Chlorhexidine Mouthwash(Rexidine® SRS).

Materials and Methods-

This study is an Interventional Prospective Clinical Trial. It is a double-blinded, single-centre, Institution-based study. The patients selected as per the inclusion and exclusion criteria, will be randomly allotted by a computerized automated randomization method into 2 groups, Group A and Group B, and treated as follow.

Group A: Scaling and chlorhexidine (Rexidine® SRS 0.2%) mouthwash

Group B: Scaling and herbal (OralifeTM) mouthwash

The following clinical parameters will be recorded at baseline (post scaling), 1 month post-scaling.

  1. Plaque Index (P.I.) (Silness and Loe, 1964)
  2. Gingival Index (G.I.) (Loe and Silness, 1963)
  3. Probing Pocket Depth (PPD)
  4. Clinical Attachment Loss(CAL)

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients in the age group between 20-60 yrs.
  • 2.Patients diagnosed with Chronic Periodontitis.
  • 3.Patients who are non smokers or do not consume tobacco in any other form.
  • 4.Patients with good systemic health.

Exclusion Criteria

  • 1.Individuals suffering from any systemic diseases.
  • Individuals wearing fixed or removable orthodontic appliances or prosthesis
  • Pregnant and lactating females
  • Individuals taking medications since prolonged duration 5.

Outcomes

Primary Outcomes

1. Plaque Index (P.I.) (Silness and Loe, 1964)

Time Frame: Baseline, 1 month Post treatment

2. Gingival Index (G.I.) (Loe and Silness, 1963)

Time Frame: Baseline, 1 month Post treatment

3. Probing Pocket Depth (PPD)

Time Frame: Baseline, 1 month Post treatment

Secondary Outcomes

  • Clinical attachment level(Baseline, 1 month post treatment)

Investigators

Sponsor
Dr Aishwary Patil
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Aishwary Patil

Nair Hospital Dental College

Study Sites (1)

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