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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06775392
Enrollment
30
Registered
2025-01-15
Start date
2024-01-04
Completion date
2024-08-05
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Pocket

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.

Interventions

DRUGbromelain-quercetin gel

bromelain-quercetin gel is prepared from capsules in laboratory

chlorhexidine gel is prepared in laboratory

PROCEDURESRP

Scaling and root planing was done with ultra sonic and hand scaling

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CLINICAL ATTACHMENT LEVEL21DAYS(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
PROBING POCKET DEPTH21DAYSmeasured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA

Secondary

MeasureTime frameDescription
Plaque Index21DAYSmeasured on the tooth surface using a probe
Gingival index21DAYSmeasured on the tooth surface using a probe
Modified Sulcus Bleeding Index21daysmeasured on the tooth surface using a probe

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026