Condition category
Oral Health
Date applied
30/06/2014
Date assigned
31/07/2014
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Long-term gum disease (chronic periodontitis) is the inflammation of the tissues around the teeth caused by dental plaque and calculus (tartar). The first phase of treatment usually consists of removal of irritants by a procedures such as scaling and root planing. Disinfectant substances may be additionally used during the procedure and are routinely recommended for the home care after such a procedure. The aim was to evaluate the effect of a new hydrophobic gingiva-adhering gel, in comparison with a standard commercially-available 1% chlorhexidine digluconate water-soluble gel, in non-surgical therapy of moderate long-term gum disease, after full mouth scaling and root planing.

Who can participate?
Adults aged 40-65 years, suffering from a long-term gum disease can take part.

What does the study involve?
The participants were randomly allocated to one of two groups. The test group received the hydrophobic gel for gentle rubbing on the gum (gingiva), once every second day for 14 days. The control group received the standard water-soluble chlorhexidine gel, daily, twice a day.

What are the possible benefits and risks of participating?
Enrolled participants will gain a complete non-surgical treatment of periodontitis. There were no side effects of treatment.

Where is the study run from?
1. The Victor Babes University of Medicine and Pharmacy of Timisoara (Romania)
2. Iuliu Hatieganu University of Medicine of Cluj (Romania)
3. University of Leipzig (Germany)

When is the study starting and how long is it expected to run for?
The study took place between January 2010 and May 2013.

Who is funding the study?
lege artis Pharma, Dettenhausen, Germany.

Who is the main contact?
Prof Stefan-Ioan Stratul
sbs@online.ro

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stefan Ioan Stratul

ORCID ID

Contact details

Victor Babes University of Medicine and Pharmacy Timisoara
Faculty of Dental Medicine
Piata
Eftimie Murgu
nr 2A
Timisoara
300041
Romania
+40 (0) 744 521 470
sbs@online.ro

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1/2010

Study information

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

Acronym

durimplant

Study hypothesis

The study tested the null hypothesis that there are no differences in the outcomes regarding the probing depth, attachment level, plaque indices, bleeding on probing, as well as subgingival microbiota and PMN-characterizing enzymes during the first 6 months after scaling and root planing.

Ethics approval

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

Study design

Randomized parallel controlled double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Periodontitis

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/01/2010

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32 calculated, 34 included

Participant 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

Recruitment start date

01/01/2010

Recruitment end date

31/05/2013

Locations

Countries of recruitment

Romania

Trial participating centre

Victor Babes University of Medicine and Pharmacy Timisoara
Timisoara
300041
Romania

Sponsor information

Organisation

lege artis Pharma GmbH + Co. KG (Germany)

Sponsor details

Breitwasenring 1
Dettenhausen
D-72135
Germany

Sponsor type

Industry

Website

http://www.legeartis.de

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes