Local drug delivery in patients suffering from chronic periodontitis using sodium cromoglycate fibres

Efficacy of sodium cromoglycate fibres local drug delivery as an adjunct to scaling and root planing and its effects on Matrixmetalloprotienases-8 levels in the management of chronic periodontitis: A clinical and biochemical study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021590

Enrollment

Registered

2019-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: Z533- Procedure converted to open procedure

Interventions

Intervention1: Sodium Cromoglycate Fibres: Local drug delivery fibres Control Intervention1: Placebo gel: Placebo gel

Eligibility

Inclusion criteria

Inclusion criteria: 1 Willingness to comply with the study protocol. 2 Subjects in the age group >=30 years without any systemic disease. 3 >=20 teeth present in the oral cavity. 4 Patients with moderate chronic periodontitis having >=2 interproximal sites, with Clinical Attachment Loss (CAL) >=4mm (not on the same tooth) and interproximal sites with Probing Pocket Depth (PPD) >=5mm, also (not on the same tooth) each tooth site in two different quadrants.

Exclusion criteria

Exclusion criteria: 1 Patient with any systemic disease. 2 Patient with aggressive periodontitis. 3 Users of tobacco in any form. 4 Patient on systemic mast cell stabilizer therapy. 5 Patient who had undergone periodontal therapy in previous 6 months. 6 Individual with known or suspected allergy to mast cell stabilizer group. 7 Pregnant or lactating women. 8 Patient with history of Antibiotic therapy for any chronic inflammatory condition within 6 months prior to study. 9 Patient not willing to give written consent

Design outcomes

Primary

Measure	Time frame
Estimating the efficacy of 1% sodium cromoglycate gel as an adjunct to scaling and root planing on the periodontal parameters Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD), Relative Attachment Level (RAL) in patients with chronic periodontitis. 2.To evaluate the role of sodium cromoglycate as mast cell stabilizer. 3. To Estimate the MMP-8 levels in GCF to evaluate the efficacy of Sodium Cromoglycate fibres subgingival local drug deliveryTimepoint: 6 months	—

Measure

Time frame

Estimating the efficacy of 1% sodium cromoglycate gel as an adjunct to scaling and root planing on the periodontal parameters Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD), Relative Attachment Level (RAL) in patients with chronic periodontitis. 2.To evaluate the role of sodium cromoglycate as mast cell stabilizer. 3. To Estimate the MMP-8 levels in GCF to evaluate the efficacy of Sodium Cromoglycate fibres subgingival local drug deliveryTimepoint: 6 months

—

Secondary

Measure	Time frame
Estimating the efficacy of 1% sodium cromoglycate gel as an adjunct to scaling and root planing on the periodontal parameters Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD), Relative Attachment Level (RAL) in patients with chronic periodontitis. 2.To evaluate the role of sodium cromoglycate as mast cell stabilizer. 3. To Estimate the MMP-8 levels in GCF to evaluate the efficacy of Sodium Cromoglycate fibres subgingival local drug deliveryTimepoint: 6 months	—

Measure

Time frame

—

Countries

India

Contacts

Public ContactStuti Gupta

Sharda university

stuti.gupta@sharda.ac.in9953742797

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026