Efficacy of Subgingivally Delivered Doxycycline Plus Ketoprofen Gel as an Adjunct to Non-surgical Periodontal Treatment

NCT02538224 | Completed Phase 2 DMC

• 1 other identifier: azadtehran
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: The aim of the present clinical study was to evaluate the efficacy of doxycyline 3% plus ketoprofen 2.5% as an adjunct to scaling and root planing in the treatment of chronic periodontitis(early-modearte). Material and Methods: 20 systemically healthy, chronic periodontitis patients were included in the study.The Patients were selected on the basis of having chronic periodontitis with periodontal pocket depths of more than 4mm on at least two teeth in mandibular molar area; Periodontal parameters (plaque, bleeding on probing and pocket depth) were recorded at baseline and every 15 days for 3 months. Oral hygiene instructions were given that included brushing twice- daily, (Using the Bass brushing technique for at least 2 minutes ), Randomly divided two groups,Test group: was treated by scaling and root planing Followed by local delivery of doxycycline 3%+ ketoprofen 2.5%, While the control group: was treated by scaling and root planing along with ketoprofen 2.5%; and was administered to the both groups every 15 days for 3 months, repeated. Every 15 days once periodontal parameters were assessed, and at the end of 3 months, evaluated the clinical parameters changes.

Conditions

Chronic Periodontitis

Keywords

Periodontitis; doxycycline/ketoprofen topical gel therapeutic

Outcome Measures

Primary Outcomes (1)

• Reduction of pocket depth

  15 days

Secondary Outcomes (1)

• Reduction of bleeding on probing

  15 days

Study Arms (2)

experimental(case): group A

ACTIVE COMPARATOR

Group A: 2.5%ketoprofen gel + 3 % doxycycline gel which(0.05cc,mixed gel) be put into the periodontal pocket using an insulin syringe;For every 15 days within 3 months .

Drug: 2.5%ketoprofen gel + 3 % doxycycline; Drug: :2.5%ketoprofen gel

control: group B

SHAM COMPARATOR

Group B: 2.5%ketoprofen gel which (0.05cc,gel)be put into the periodontal pocket using an insulin syringe;For every 15 days within 3 months .

Drug: :2.5%ketoprofen gel

Interventions

2.5%ketoprofen gel + 3 % doxycycline DRUG

GroupA:(0.05cc, mixed gel) be put into the periodontal pocket using an insulin syringe. Intervention category Treatment: drugs

Also known as: Experimental

experimental(case): group A

:2.5%ketoprofen gel DRUG

GroupB:2.5%ketoprofen gel which be inserted into the periodontal pocket using an insulin syringe .

Also known as: control

control: group B; experimental(case): group A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients,
• older than 18 years old,
• systemically healthy, and
• having at least 20 teeth.

You may not qualify if:

• patients with cavitated caries,
• no periodontal pockets larger than 4 mm,
• orthodontic appliances or removable prostheses,
• allergies to cetylpyridinium or CHX,
• use of antibiotics and anti-inflammatory drugs in the past 3 months that might alter normal gingival health,
• oral prophylaxis outside of study;
• use of oral chlorhexidine products or participation in an oral rinse study within 3 months prior to baseline examination,
• pregnancy or lactation,
• smoking.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• amirhossein farahmand, assoc prof

  azad tehran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: azadtehran

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: September 2, 2015
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 6, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share