Periodontal PocketPhase 1NCT06775392
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
A Phase 1 study testing bromelain-quercetin gel, chlorhexidine gel and SRP in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- bromelain-quercetin gel, chlorhexidine gel and SRP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 4 Jan 2024to 5 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
India1 site
Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI
Bengaluru, Karnataka, 562157
About this study
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
Read the 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.
- Conditions
- Periodontal Pocket
- Being tested
- bromelain-quercetin gel, chlorhexidine gel, SRP
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bromelain-quercetin gelDrug
bromelain-quercetin gel is prepared from capsules in laboratory
chlorhexidine gelDrug
chlorhexidine gel is prepared in laboratory
SRPProcedure or surgery
Scaling and root planing was done with ultra sonic and hand scaling
| Study group | Role | What they receive |
|---|---|---|
| Group-1-SRP alone | Active comparator | control group is treated with SRP alone Receives: Procedure: SRP |
| Group-2-2%bromelain-quercetin gel | Experimental | test group treated with 2%bromelain-quercetin gel Receives: Drug: bromelain-quercetin gel |
| Group-3-0.2% chlorhexidine gel | Active comparator | test group treated with chlorhexidine gel Receives: Drug: chlorhexidine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROBING POCKET DEPTH
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
Measured: 21DAYS
CLINICAL ATTACHMENT LEVEL
(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
Measured: 21DAYS
Secondary outcomes (3)
Plaque Index
measured on the tooth surface using a probe
Measured: 21DAYS
Gingival index
measured on the tooth surface using a probe
Measured: 21DAYS
Modified Sulcus Bleeding Index
measured on the tooth surface using a probe
Measured: 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start4 Jan 2024
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775392
- Sponsor's protocol ID
- KCDSHEC/IP/2023/V1/P4a
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06775392
- Acronym / sponsor ID
- KCDSHEC/IP/2023/V1/P4a
- Conditions
- Periodontal Pocket
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-1-SRP alone | Active comparator | Procedure: SRPcontrol group is treated with SRP alone |
| Group-2-2%bromelain-quercetin gel | Experimental | Drug: bromelain-quercetin geltest group treated with 2%bromelain-quercetin gel |
| Group-3-0.2% chlorhexidine gel | Active comparator | Drug: chlorhexidine geltest group treated with chlorhexidine gel |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bromelain-quercetin gelbromelain-quercetin gel is prepared from capsules in laboratory | Drug | Group-2-2%bromelain-quercetin gel |
| chlorhexidine gelchlorhexidine gel is prepared in laboratory | Drug | Group-3-0.2% chlorhexidine gel |
| SRPScaling and root planing was done with ultra sonic and hand scaling | Procedure or surgery | Group-1-SRP alone |
Primary outcome
PROBING POCKET DEPTH
Time frame: 21DAYS
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
CLINICAL ATTACHMENT LEVEL
Time frame: 21DAYS
(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
3 secondary outcomes
Plaque Index
Time frame: 21DAYS
Gingival index
Time frame: 21DAYS
Modified Sulcus Bleeding Index
Time frame: 21days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bromelain-quercetin gel, chlorhexidine gel and SRP in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROBING POCKET DEPTH (time frame: 21DAYS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.