Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.

NCT04605289 | Completed Phase 1 DMC

• 1 other identifier: 17102019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8).

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Changes of clinical attachment and periodontal probing pocket

  Millimeters (mm)

  at baseline and twelve weeks from intervention.

Secondary Outcomes (1)

• GCF concentration of MMP-8

  at baseline, one week, and twelve weeks from intervention.

Study Arms (2)

Group I (study group)

EXPERIMENTAL

Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel

Drug: lemongrass essential oil gel; Procedure: Scaling and root planing

Group II (control group)

PLACEBO COMPARATOR

Scaling and root planing +intra-pocket application of placebo gel

Drug: Placebo; Procedure: Scaling and root planing

Interventions

lemongrass essential oil gel DRUG

The lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.

Also known as: Cymbopogon citratus oil gel

Group I (study group)

Placebo DRUG

The placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.

Also known as: Carbopol®-Based pH-Sensitive gel

Group II (control group)

Scaling and root planing PROCEDURE

Conventional mechanical treatment by ultra-sonic scalers

Group I (study group); Group II (control group)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes having moderate periodontitis (stage II), CAL 3-4mm.
• Patients' age between 25 and 45 years old.
• Systemically healthy patients.
• No history of periodontal therapy (surgical and non-surgical) or taken any antibiotic therapy for the past six months.

You may not qualify if:

• History of smoking.
• Patients having previous adverse reaction to the products (or similar products) used in this study.
• Grade C category that has rapid rate of progression.
• Pregnant and lactating women.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (62)

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MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Nadein E Sharif

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A student of Master's degree

Model Details: -Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 28, 2020
• Study Start: January 13, 2020
• Primary Completion: August 31, 2020
• Study Completion: October 14, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)