Comparison between two chlorhexidine gels for treatment of chronic periodontitis

• Register: ISRCTN
• Last refreshed on: 5 January 2021
• Main ID: ISRCTN35210084
• Date of registration: 31/07/2014
• Prospective Registration: No
• Primary sponsor: lege artis Pharma GmbH + Co. KG (Germany)
• Public title: Comparison between two chlorhexidine gels for treatment of chronic periodontitis
• Scientific title: Evaluation of a hydrophobic gel adhering to the gingiva in comparison with a standard water soluble 1% chlorhexidine gel after full mouth scaling and root planing in patients with moderate chronic periodontitis: a randomized clinical trial
• Date of first enrolment: 01/01/2010
• Target sample size: 34
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN35210084
• Study type: Interventional
• Study design: Randomized parallel controlled double-blind trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Romania

Contacts

• Name: Stefan Ioan Stratul

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age between 40 ? 65 years old,
2. Moderate chronic periodontitis (two or more interproximal sites with = 4 mm clinical CAL [not on the same tooth] or two or more interproximal sites with = 5 mm PD, also not on the same tooth [according to the CDC-AAP definition])
3. At least 20 teeth present in the mouth
4. No periodontal therapy during the last 2 years
5. No antibiotic or anti-inflammatory drugs intake during the last 6 months before baseline examination
6. Absence of fixed or removable prosthesis
7. Good general health

Exclusion criteria:
1. Either pregnant or nursing
2. Any diseases with influence on the periodontal diseases
3. Allergies to the components of the products used in the study


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Periodontitis
Oral Health
Periodontitis

Intervention(s)

Full mouth scaling and root planing, application of a novel hydrophobic gingiva-adhering chlorhexidine-based gel with complex composition vs a standard commercially available 1% chlorhexidine digluconate water-soluble gel.

Primary Outcome(s)

Clinical measurements and photographs were taken at baseline and at follow-up post-operatory 3 and 6 months for both primary and secondary outcome measures.
1. Clinical attachment level
2. Frequency of detection of periodontopathogenic bacteria
3. Enzymatic activity of neutrophil elastase and myeloperoxidase

Secondary Outcome(s)

1. Pocket depth
2. Gingival recession
3. Plaque indices

Secondary ID(s)

1/2010

Source(s) of Monetary Support

lege artis Pharma GmbH + Co. KG, Dettenhausen, Germany

Ethics review

Status:
Approval date:
Contact:

1. Ethics Committees of the Faculty of Medicine of the University of Leipzig, ref. approval No.190 2009 2. Victor Babes University of Medicine and Pharmacy of Timisoara, ref. 12/14.12.2009

Results

• Results available: Yes
• Date Completed: 31/05/2013