Periodontal DiseasesPhase 4NCT07135674
Evaluation of a Herbal Antiseptic Gel as a Supportive Treatment for Teeth Cleaning in Patients With Periodontal Disease
A Phase 4 study testing herbal drug in people with Periodontal Diseases, run by Rungta College of Dental Sciences and Research at 1 site in India.
Trial summary
The goal of this clinical trial is to learn if the herbal gel is more effective as compared to placebo in reducing periodontal inflammation in patients with periodontal disease. The clinicians shall check various periodontal parameters in the subjects over a scheduled duration. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- herbal drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 30 May 2023to 30 May 2025
- Phase
- Phase 4
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- history of any systemic disease, Antibiotic treatment during the 6 months period prior to the study, Pregnant and lactating woman, Periodontal treatment during the previous 3 months, Severe caries or extensive restoration on the objective teeth.
Trial locations and contacts
1 site in 1 country.
India1 site
Rungta College of Dental Sciences and Research
Durg, Chhattisgarh, 490024
About this study
Official title: Evaluation of Thermoreversible Avocado-based Gel as an Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients: A Clinical And Microbiological Study
The goal of this clinical trial is to learn if the herbal gel is more effective as compared to placebo in reducing periodontal inflammation in patients with periodontal disease.
The clinicians shall check various periodontal parameters in the subjects over a scheduled duration.
Participants will be administered the gel once subgingivally and the periodontal parameters shall be recorded before gel delivery then again after 1,3 and 6 months.
Plaque samples were taken at baseline and 6 months
Read the detailed description
Chronic periodontitis is a prevalent inflammatory condition primarily caused by bacterial plaque biofilm, leading to progressive attachment and bone loss. Scaling and root planing (SRP) is the gold standard for its management. Recently, natural and herbal-based adjuncts have gained attention for their antimicrobial and anti-inflammatory properties. This study aimed to evaluate the clinical and microbiological effectiveness of 4% avocado gel as an adjunct to SRP in the treatment of chronic periodontitis.
A randomized controlled clinical trial was conducted on patients diagnosed with chronic periodontitis. Subjects were divided into two groups: Group I received SRP with subgingival application of placebo gel, and Group II received SRP along with subgingival application of 4% avocado gel. Clinical parameters, including Plaque Index (PI), Papilla Bleeding Index (PBI), Probing Pocket Depth (PPD), and Relative Attachment Level (RAL), were recorded at baseline and after 4th week and 12th week. Microbiological analysis was conducted at recorded at baseline, 4th week,12th week and 24th week to assess the presence of Porphyromonas gingivalis and Prevotella intermedia using culture methods.
- Conditions
- Periodontal Diseases
- Being tested
- placebo gel, herbal drug
- Keywords
- periodontitis, P. gingivalis, P. intermedia, local drug delivery
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo gelDrug
local drug delivery of placebo gel
herbal drugDrug
local drug delivery of herbal gel
| Study group | Role | What they receive |
|---|---|---|
| scaling and root planing with subgingival application of placebo gel | Placebo comparator | scaling and root planing of the entire dentition followed by subgingival application of placebo gel in selected site Receives: Drug: placebo gel |
| scaling and root planing with subgingival application of thermoreversible herbal gel | Experimental | scaling and root planing of the entire dentition followed by subgingival application of herbal gel in selected site Receives: Drug: herbal drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papilla Bleeding Index
Measured: 3 months
Plaque Index
Measured: 3 months
Probing Pocket Depth
Measured: 3 months
Relative Attachment Level
Measured: 3 months
Secondary outcomes (1)
CFUs
Colony Forming Units
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start30 May 2023
- Primary completion30 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rungta College of Dental Sciences and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Krishna M, Rungta College of Dental Sciences and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135674
- Sponsor's protocol ID
- RCDSR/IEC/MDS/2023/D-37
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thermoreversible Avocado-based Gel as an Adjunct to Scaling and Root Planing in Chronic Periodontitis Patients: A Clinical And Microbiological Study
- ClinicalTrials.gov ID
- NCT07135674
- Acronym / sponsor ID
- RCDSR/IEC/MDS/2023/D-37
- Conditions
- Periodontal Diseases
- Keywords
- periodontitis, P. gingivalis, P. intermedia, local drug delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rungta College of Dental Sciences and ResearchUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 22 Aug 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.
The goal of this clinical trial is to learn if the herbal gel is more effective as compared to placebo in reducing periodontal inflammation in patients with periodontal disease.
The clinicians shall check various periodontal parameters in the subjects over a scheduled duration.
Participants will be administered the gel once subgingivally and the periodontal parameters shall be recorded before gel delivery then again after 1,3 and 6 months.
Plaque samples were taken at baseline and 6 months
Detailed description
Chronic periodontitis is a prevalent inflammatory condition primarily caused by bacterial plaque biofilm, leading to progressive attachment and bone loss. Scaling and root planing (SRP) is the gold standard for its management. Recently, natural and herbal-based adjuncts have gained attention for their antimicrobial and anti-inflammatory properties. This study aimed to evaluate the clinical and microbiological effectiveness of 4% avocado gel as an adjunct to SRP in the treatment of chronic periodontitis.
A randomized controlled clinical trial was conducted on patients diagnosed with chronic periodontitis. Subjects were divided into two groups: Group I received SRP with subgingival application of placebo gel, and Group II received SRP along with subgingival application of 4% avocado gel. Clinical parameters, including Plaque Index (PI), Papilla Bleeding Index (PBI), Probing Pocket Depth (PPD), and Relative Attachment Level (RAL), were recorded at baseline and after 4th week and 12th week. Microbiological analysis was conducted at recorded at baseline, 4th week,12th week and 24th week to assess the presence of Porphyromonas gingivalis and Prevotella intermedia using culture methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scaling and root planing with subgingival application of placebo gel | Placebo comparator | Drug: placebo gelscaling and root planing of the entire dentition followed by subgingival application of placebo gel in selected site |
| scaling and root planing with subgingival application of thermoreversible herbal gel | Experimental | Drug: herbal drugscaling and root planing of the entire dentition followed by subgingival application of herbal gel in selected site |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- history of any systemic disease, Antibiotic treatment during the 6 months period prior to the study, Pregnant and lactating woman, Periodontal treatment during the previous 3 months, Severe caries or extensive restoration on the objective teeth.
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 |
|---|---|---|
| placebo gellocal drug delivery of placebo gel | Drug | scaling and root planing with subgingival application of placebo gel |
| herbal druglocal drug delivery of herbal gel | Drug | scaling and root planing with subgingival application of thermoreversible herbal gel |
Primary outcome
Papilla Bleeding Index
Time frame: 3 months
Plaque Index
Time frame: 3 months
Probing Pocket Depth
Time frame: 3 months
Relative Attachment Level
Time frame: 3 months
1 secondary outcome
CFUs
Time frame: 6 months
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 22 Aug 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 4 study testing herbal drug in people with Periodontal Diseases, run by Rungta College of Dental Sciences and Research 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 0 inclusion and 1 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 22 Aug 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Papilla Bleeding Index (time frame: 3 months). The study lists 4 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 22 Aug 2025.