Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HY containing gel; GUM® Afta Clear Gel, Sunstar
saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
test group
Arm Description
saline solution
HY containing gel; GUM® Afta Clear Gel, Sunstar
Outcomes
Primary Outcome Measures
residual periodontal pockets
number of experimental sites showing PD < 5 mm or no PD ≥ 5 mm + BoP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04792541
Brief Title
Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.
Official Title
Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malmö University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
saline solution
Arm Title
test group
Arm Type
Experimental
Arm Description
HY containing gel; GUM® Afta Clear Gel, Sunstar
Intervention Type
Other
Intervention Name(s)
HY containing gel; GUM® Afta Clear Gel, Sunstar
Intervention Type
Other
Intervention Name(s)
saline solution
Primary Outcome Measure Information:
Title
residual periodontal pockets
Description
number of experimental sites showing PD < 5 mm or no PD ≥ 5 mm + BoP
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
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Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.
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