CClinicalTrials.gg
Not yet recruitingNCT06050863Updated Sep 22, 2023

Local Delivery of Silk Fibroin and Chlorhexidine

A Phase 1 interventional study of silk fibroin and Chlorhexidin in Periodontal Pocket, sponsored by Krishnadevaraya College of Dental Sciences & Hospital. Not yet recruiting. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Krishnadevaraya College of Dental Sciences & Hospital · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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 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.

  1. Group I (SRP+ Silk Fibroin)
  2. Group II (SRP+ Chlorhexidine)
  3. 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.
02

Conditions studied

  • Periodontal Pocket

Browse trials for

03

In context

Periodontal Pocket

126 studies on the registry are indexed under Periodontal Pocket; 36 are open to participants now.

This study's planned enrollment of 15 is below the median of 30 across 109 interventional studies indexed under Periodontal Pocket.

Browse Periodontal Pocket studies →

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital is the lead sponsor of 51 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patient with age between 30-50 years.
  2. Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered.
  3. Patients with localized periodontal pockets.
  4. Patients willing to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Patients with known systemic diseases.
  2. Non complaint patients.
  3. Patients who received any surgical or nonsurgical therapy 6 months before the start of the study.
  4. Pregnant or lactating females.
  5. Use of systemic antibiotics in the past 6 months.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Group I - Silk Fibroin

    test group 1 is treated with silk fibroin

    Biological: silk fibroin

  • Active comparator
    Group II -Chlorhexidine

    test group 2 is treated with chlorhexidine

    Drug: Chlorhexidin

  • Experimental
    Group III - Combination of Fibroin and Chlorhexidine

    test group 3 is treated with combination of silk fibroin and chlorhexidine

    Biological: combination of silk fibroin and chlorhexidine

Interventions

  • Biologicalsilk fibroin

    silk fibroin extracted from bombyx mori silk worm is processed in laboratory to form silk fibroin films

  • DrugChlorhexidin

    chlorhexidine is used

    Also known as: chlorhexidine

  • Biologicalcombination of silk fibroin and chlorhexidine

    combination of silk fibroin and chlorhexidine is used

06

What researchers measure

Primary outcomes

  1. Probing pocket Depth (PPD)

    measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA

    Time frame: 3 months

  2. 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)

    Time frame: 3 months

Secondary outcomes

  1. Plaque Index

    measured on the tooth surface using a probe

    Time frame: 3 months

  2. Gingival index

    measured on the tooth surface using a probe

    Time frame: 3 month

  3. Modified Sulcus Bleeding Index

    measured on the tooth surface using a probe

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06050863
Lead sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible party
Sponsor
First posted
Sep 22, 2023
Start date
Nov 2023 (estimated)
Primary completion
Jun 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Sep 22, 2023

Study contacts

DR .Prabhuji MLV, MDS
Contact
prabhujimlv@gmail.com
9448057407 ext. 91
DR. Aishwarya s, MDS
Contact
draishwarya1996@gmail.com
9686404461 ext. 91

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion