Periodontal PocketPhase 1NCT06050863
Local Delivery of Silk Fibroin and Chlorhexidine
A Phase 1 study testing silk fibroin, Chlorhexidin and combination of silk fibroin and chlorhexidine in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital.
Trial summary
The current study is a prospective randomised split mouth study to evaluate the effect of Silk fibroin as drug delivery system while simultaneously assessing the efficacy of silk fibroin in comparison to chlorhexidine. 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?
- silk fibroin, Chlorhexidin and combination of silk fibroin and chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jul 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 age between 30-50 years.
- Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered.
- Patients with localized periodontal pockets.
- Patients willing to participate in the study.
Who cannot join
- Patients with known systemic diseases.
- Non complaint patients.
- Patients who received any surgical or nonsurgical therapy 6 months before the start of the study.
- Pregnant or lactating females.
- Use of systemic antibiotics in the past 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Evaluation of Subgingivally Delivered Chlorhexidine, Silk Fibroin and Combination of Fibroin and Chlorhexidine as Local Drug Delivery in Periodontitis - A Randomized Control Trial
The current study is a prospective randomised split mouth study to evaluate the effect of Silk fibroin as drug delivery system while simultaneously assessing the efficacy of silk fibroin in comparison to chlorhexidine.
Read the detailed description
Fifteen healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.All the patients underwent scaling and root planing.
Following randomization, the site will be assigned to one of the three study groups.
- Group I (SRP+ Silk Fibroin)
- Group II (SRP+ Chlorhexidine)
- Group III (SRP+ Combination of Fibroin and Chlorhexidine) Periodotal pack was placed and patient was recalled after 21days, 1 month and 3 month for the follow up.
- Conditions
- Periodontal Pocket
- Being tested
- silk fibroin, Chlorhexidin, combination of silk fibroin and chlorhexidine
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silk fibroinBiological
silk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films
ChlorhexidinDrug
Also called chlorhexidine
chlorhexidine is used
combination of silk fibroin and chlorhexidineBiological
combination of silk fibroin and chlorhexidine is used
| Study group | Role | What they receive |
|---|---|---|
| Group I - Silk Fibroin | Experimental | test group 1 is treated with silk fibroin Receives: Biological: silk fibroin |
| Group II -Chlorhexidine | Active comparator | test group 2 is treated with chlorhexidine Receives: Drug: Chlorhexidin |
| Group III - Combination of Fibroin and Chlorhexidine | Experimental | test group 3 is treated with combination of silk fibroin and chlorhexidine Receives: Biological: combination of silk fibroin and chlorhexidine |
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)
measured by placing the acrylic stent on the selected teeth using UNC-15 probe (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 posted22 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (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
- 15 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
- NCT06050863
- Sponsor's protocol ID
- 02_D012_126027
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 22 Sep 2023
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Subgingivally Delivered Chlorhexidine, Silk Fibroin and Combination of Fibroin and Chlorhexidine as Local Drug Delivery in Periodontitis - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06050863
- Acronym / sponsor ID
- 02_D012_126027
- Conditions
- Periodontal Pocket
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 22 Sep 2023 (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 split mouth study to evaluate the effect of Silk fibroin as drug delivery system while simultaneously assessing the efficacy of silk fibroin in comparison to chlorhexidine.
Detailed description
Fifteen healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.All the patients underwent scaling and root planing.
Following randomization, the site will be assigned to one of the three study groups.
- Group I (SRP+ Silk Fibroin)
- Group II (SRP+ Chlorhexidine)
- Group III (SRP+ Combination of Fibroin and Chlorhexidine) Periodotal pack was placed and patient was recalled after 21days, 1 month and 3 month for the follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I - Silk Fibroin | Experimental | Biological: silk fibrointest group 1 is treated with silk fibroin |
| Group II -Chlorhexidine | Active comparator | Drug: Chlorhexidintest group 2 is treated with chlorhexidine |
| Group III - Combination of Fibroin and Chlorhexidine | Experimental | Biological: combination of silk fibroin and chlorhexidinetest group 3 is treated with combination of silk fibroin and chlorhexidine |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient with age between 30-50 years.
- Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered.
- Patients with localized periodontal pockets.
- Patients willing to participate in the study.
Key exclusion criteria (5 listed)
- Patients with known systemic diseases.
- Non complaint patients.
- Patients who received any surgical or nonsurgical therapy 6 months before the start of the study.
- Pregnant or lactating females.
- Use of systemic antibiotics in the past 6 months.
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 |
|---|---|---|
| silk fibroinsilk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films | Biological | Group I - Silk Fibroin |
| ChlorhexidinAlso: chlorhexidinechlorhexidine is used | Drug | Group II -Chlorhexidine |
| combination of silk fibroin and chlorhexidinecombination of silk fibroin and chlorhexidine is used | Biological | Group III - Combination of Fibroin and Chlorhexidine |
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
measured by placing the acrylic stent on the selected teeth using UNC-15 probe (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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing silk fibroin, Chlorhexidin and combination of silk fibroin and chlorhexidine in people with Periodontal Pocket, run by Krishnadevaraya College of Dental Sciences & Hospital.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR .Prabhuji MLV, MDS (9448057407 ext. 91, 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 22 Sep 2023.