Local Delivery of Silk Fibroin and Chlorhexidine

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06050863

Enrollment

Registered

2023-09-22

Start date

2023-11-30

Completion date

2024-07-31

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Pocket

Brief 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.

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.

Interventions

BIOLOGICALsilk fibroin

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

DRUGChlorhexidin

chlorhexidine is used

BIOLOGICALcombination of silk fibroin and chlorhexidine

combination of silk fibroin and chlorhexidine is used

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 50 Years

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

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.

Design outcomes

Primary

Measure	Time frame	Description
Probing pocket Depth (PPD)	3 months	measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
Relative attachment level (RAL)	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)

Secondary

Measure	Time frame	Description
Plaque Index	3 months	measured on the tooth surface using a probe
Gingival index	3 month	measured on the tooth surface using a probe
Modified Sulcus Bleeding Index	3 months	measured on the tooth surface using a probe

Contacts

Primary ContactDR .Prabhuji MLV, MDS

prabhujimlv@gmail.com9448057407

Backup ContactDR. Aishwarya s, MDS

draishwarya1996@gmail.com9686404461

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026