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Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.

NCT04792541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-03-15

No results posted yet for this study

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.

Conditions

  • Periodontitis

Interventions

OTHER

HY containing gel; GUM® Afta Clear Gel, Sunstar

OTHER

saline solution

Sponsors & Collaborators

  • Malmö University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-02-08
Completion
2021-02-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04792541 on ClinicalTrials.gov