- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792541
Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.
Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
Aim To evaluate the clinical and microbiological effects of a hyaluronan (HY) as adjunct to scaling and root planning of residual pockets during supportive periodontal therapy.
Material and Methods Sixty-six chronic periodontitis, that have completed the active phase of treatment and are enrolled in a supportive periodontal therapy scheme, with 4 to 8 interproximal sites with PD ≥ 5 mm < 8 mm and presence of BoP at the revaluation examination will be randomly assigned to the test (HY containing gel) or control group. Immediately after debridement of the residual pockets the test gel (GUM® Afta Clear Gel, Sunstar) will be applied into the experimental sites by the operator. Further, the participants will be instructed to apply at the experimental sites the test gel supragingivally with an interdental brush (TePe, Malmö, Sweden), once per day after tooth brushing for the first 3 months. Subgingival gel application will be repeated at the 3-month control in persistent pockets (i.e. PD ≥ 5mm + BoP). CAL, PD, BoP, and presence of plaque will be evaluated at baseline and thereafter every 3 months (i.e., after 3, 6, 9, and 12 months). Further, subgingival microbiological samples will be collected from the 4 experimental sites at baseline, 3, 6, and 12 months. Nine periodontal pathogens (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra, Campylobacter rectus, Eikenella corrodens), total bacterial load, and amount of Candida albicans will be determined quantitatively by real-time PCR.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim The aim of this project is to evaluate the clinical and microbiological effects of a HY as adjunct to scaling and root planning of residual pockets during supportive periodontal therapy. The primary hypothesis is that application of HY as adjunct to debridement of residual pockets in chronic periodontitis patients results in a significantly higher number of sites with reduced risk for further disease progression (i.e. attachment loss) after debridement.
Background Hyaluronan (HY) is a naturally occurring high molecular weight glycosaminoglycan present in various body fluids and tissues, and shows bacteriostatic, fungistatic, anti-inflammatory, anti-oedematous, osteoinductive, and pro-angiogenetic properties. A recently published systematic review (Bertl et al. 2015a) of controlled studies on the use of HY in non-surgical and surgical periodontal treatment showed that HY as adjunct to non-surgical and/or surgical periodontal therapy that HY has a positive, albeit moderate, effect in favour of in terms of BOP and residual PD, compared to controls. However, due to large heterogeneity of included studies, no recommendations on the mode of application or the effect size of HY as adjunct to non-surgical and surgical periodontal treatment could be made.
Material and Methods Sixty-six chronic periodontitis, that have completed the active phase of treatment and are enrolled in a supportive periodontal therapy scheme, with 4 to 8 interproximal sites with PD ≥ 5 mm < 8 mm and presence of BoP at the revaluation examination will be randomly assigned to the test (HY containing gel) or control group. Immediately after debridement of the residual pockets the test gel (GUM® Afta Clear Gel, Sunstar) will be applied into the experimental sites by the operator. Further, the participants will be instructed to apply at the experimental sites the test gel supragingivally with an interdental brush (TePe, Malmö, Sweden), once per day after tooth brushing for the first 3 months. Subgingival gel application will be repeated at the 3-month control in persistent pockets (i.e. PD ≥ 5mm + BoP). CAL, PD, BoP, and presence of plaque will be evaluated at baseline and thereafter every 3 months (i.e., after 3, 6, 9, and 12 months).
Further, subgingival microbiological samples will be collected from the 4 experimental sites at baseline, 3, 6, and 12 months. Nine periodontal pathogens (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra, Campylobacter rectus, Eikenella corrodens), total bacterial load, and amount of Candida albicans will be determined quantitatively by real-time PCR.
Significance So far any possible beneficial effect of HY containing products in the treatment of residual pockets during supportive periodontal treatment has not been assessed. It seems relevant to assess whether the positive effect of HY when applied as adjunct to scaling and root planning of residual pockets during supportive periodontal therapy, may reduce the risk for further disease progression and/or the need for periodontal surgery, compared to debridement alone.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of chronic periodontitis
- at least 10 teeth
- 4 to 8 interproximal sites with PD ≥ 5 to < 8 mm and presence of BoP at the revaluation examination
- no molar with furcation involvement (Class II or III)
- no difference in PD > 2 mm next to the experimental site
Exclusion Criteria:
- antibiotic therapy or active periodontal treatment in the previous 6 months
- long-term use of anti-inflammatory and immunosuppressive medication
- diabetes
- pregnancy or lactatio
- need for antibiotics prophylaxis
- severe occlusal dysfunction
- orthodontic treatment
- class II or III tooth mobility
- endodontic problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
saline solution
|
|
Experimental: test group
HY containing gel; GUM® Afta Clear Gel, Sunstar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
residual periodontal pockets
Time Frame: 12 months
|
number of experimental sites showing PD < 5 mm or no PD ≥ 5 mm + BoP
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HY_residual
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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