Clinical trial NCT06775392: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periodontal Pocket
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: PROBING POCKET DEPTH
timeFrame: 21DAYS
measure: CLINICAL ATTACHMENT LEVEL
timeFrame: 21DAYS
Secondary outcomes:
measure: Plaque Index
timeFrame: 21DAYS
measure: Gingival index
timeFrame: 21DAYS
measure: Modified Sulcus Bleeding Index
timeFrame: 21days
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI
state: Karnataka
Study officials:
References: