Periodontal PocketPhase 1NCT06505759
Evaluation of 2%Bromelain Gel With 0.2%CHX Gel as Subgingival LDD Following SRP in Stage II/III and Grade B Periodontitis -A RCT
A Phase 1 study testing Bromelain 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
The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis 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 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
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2024to Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI
Bengaluru, Karnataka, 562157
Dr. MLV Prabhuji
About this study
Official title: Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis -Randomized Control Clinical Trail
The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis
Read the detailed description
36 sites with periodontal pocket depth measuring 4-6mm were selected. The sites selected were divided into
- Group I (Control)- 12 sites with Probing depth of ≥5mm treated with scaling and root planing alone.
- Group II -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of bromelain gel.
- Group III -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of chlorhexidine gel. periodontal pack was placed and patient was recalled at 1week,4th week and 12th week
- Conditions
- Periodontal Pocket
- Being tested
- Bromelain 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 gelDrug
bromelain gel is prepared from bromelain capsules in laboratory
chlorhexidine gelDrug
chlorhexidine gel is prepared from mouth wash
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 2-0.2% BROMELAIN gel | Experimental | test group is treated with bromelain gel Receives: Drug: Bromelain gel |
| GROUP 3-0.2% CHLORHEXIDINE gel | Active comparator | test group is 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 (PPD)
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
Measured: 3 months
Relative attachment level (RAL)
(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
Measured: 3 months
Secondary outcomes (3)
Plaque Index
measured on the tooth surface using a probe
Measured: 3 months
Gingival index
measured on the tooth surface using a probe
Measured: 3 month
Modified Sulcus Bleeding Index
measured on the tooth surface using a probe
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
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
- 36 participants (estimated)
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
- NCT06505759
- Sponsor's protocol ID
- 02-D012-147453
- Status last verified
- Jan 2025
- First submitted
- 11 Jul 2024
- Last updated
- 13 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis -Randomized Control Clinical Trail
- ClinicalTrials.gov ID
- NCT06505759
- Acronym / sponsor ID
- 02-D012-147453
- Conditions
- Periodontal Pocket
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 Jul 2024 (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.
The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis
Detailed description
36 sites with periodontal pocket depth measuring 4-6mm were selected. The sites selected were divided into
- Group I (Control)- 12 sites with Probing depth of ≥5mm treated with scaling and root planing alone.
- Group II -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of bromelain gel.
- Group III -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of chlorhexidine gel. periodontal pack was placed and patient was recalled at 1week,4th week and 12th week
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 2-0.2% BROMELAIN gel | Experimental | Drug: Bromelain geltest group is treated with bromelain gel |
| GROUP 3-0.2% CHLORHEXIDINE gel | Active comparator | Drug: chlorhexidine geltest group is 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 gelbromelain gel is prepared from bromelain capsules in laboratory | Drug | GROUP 2-0.2% BROMELAIN gel |
| chlorhexidine gelchlorhexidine gel is prepared from mouth wash | 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 (PPD)
Time frame: 3 months
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
Relative attachment level (RAL)
Time frame: 3 months
(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
3 secondary outcomes
Plaque Index
Time frame: 3 months
Gingival index
Time frame: 3 month
Modified Sulcus Bleeding Index
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Related trials for Periodontal Pocket
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Not yet recruitingPhase 2
Effect of Gingival Mesenchymal Stem Cell-Derived Small Extracellular Vesicles in Management of Infra-bony Periodontal Defect
Infra-bony Periodontal Defect
Not yet recruiting
Diode Laser 635 nm and 810 nm Photodynamic Therapy as Adjuncts to Non-Surgical Periodontal Treatment
Periodontitis
Not yet recruiting
Clinical Effectiveness of Oxygen-Releasing Oral Gel as an Adjunct to Scaling and Root Debridement in Patients With Severe Periodontal Pockets: A Randomized Clinical Trial
Periodontitis
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.
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 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: looking for participants now, as of the sponsor's last update on 13 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DR .Prabhuji MLV, MDS (9448057407, prabhujimlv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket Depth (PPD) (time frame: 3 months). 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 13 Jan 2025.