Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

Krishnadevaraya College of Dental Sciences & Hospital

Status and phase: Completed; Phase 1

Conditions: Periodontal Pocket

Treatments: Procedure: SRP; Drug: chlorhexidine gel; Drug: bromelain-quercetin gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06775392

KCDSHEC/IP/2023/V1/P4a

Details and patient eligibility

About

Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

Full description

: Periodontitis is a biofilm associated disease that induces an irreversible inflammatory state that leads to the destruction of the supporting structure of the teeth. Management of periodontal disease is through thorough removal of biofilm which is pivotal for having better oral health. Scaling and root planning (SRP) is fundamental treatment for periodontitis. Years of documented research have established that chlorhexidine digluconate (CHX), gold standard of chemical plaque control agent is safe stable and effective in preventing and controlling plaque formation. Bromelain is an extract derived from Ananas comosus (popularly known as pineapple), contains proteinases that exhibits anti-inflammatory properties, antibacterial effect against periodontopathogens. Bromelain gel has shown to have chemicomechanical method of caries removal. Quercetin present in guava have excellent antibacterial actions against periodontal pathogens, Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Fusobacterium nucleatum (Fn). 2% Quercetin has shown to be advantageous for subgingival application after scaling and rootplaning. Bromelain-Quercetin gel has shown adjunctive effect for treatment in covid-19 patients. As there is less literature in this combination, we intend to study its effects. Individually bromelain and quercetin have been studied for treatment in oral cavity as gel form. This study will be first of its kind to check the efficacy of 2% bromelain-quercetin gel and to compare its effects with 0.2% Chlorhexidine in stage I/II and grade B periodontits.

Enrollment: 30 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient with have chronic periodontitis in the age group between 30-50 years.

• Patients having ≥20 teeth.

  -.Patients with radiographic evidence of bone loss in atleast two teeth.

• Patients who are systematically healthy.

• Patients with localized pockets with probing depth of ≤ 5mm.

• Patients who are cooperative and able to attend the hospital for regular follow-up.

Exclusion criteria

• Patients who have received any surgical or nonsurgical therapy during past 6months
• Pregnant or lactating females.
• Use of systemic antibiotics in the past 6 months.
• Patient who are not willing to give a written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Group-1-SRP alone

Active Comparator group

Description:

control group is treated with SRP alone

Treatment:

Procedure: SRP

Group-2-2%bromelain-quercetin gel

Experimental group

Description:

test group treated with 2%bromelain-quercetin gel

Treatment:

Drug: bromelain-quercetin gel

Group-3-0.2% chlorhexidine gel

Active Comparator group

Description:

test group treated with chlorhexidine gel

Treatment:

Drug: chlorhexidine gel