Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.

NCT04792541 | Completed

• 1 other identifier: HY_residual
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• residual periodontal pockets

  number of experimental sites showing PD \< 5 mm or no PD ≥ 5 mm + BoP

  12 months

Study Arms (2)

control group

PLACEBO COMPARATOR

saline solution

Other: saline solution

test group

EXPERIMENTAL

HY containing gel; GUM® Afta Clear Gel, Sunstar

Other: HY containing gel; GUM® Afta Clear Gel, Sunstar

Interventions

HY containing gel; GUM® Afta Clear Gel, Sunstar OTHER

test group

saline solution OTHER

control group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of chronic periodontitis
• at least 10 teeth
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Malmö University: lead

Related Publications (1)

• Bertl K, Vlachou S, Pandis N, Zampelis A, Stavropoulos A. Repeated local delivery of hyaluronic acid gel as adjunctive treatment of residual pockets in periodontitis patients undergoing supportive periodontal care. A randomized controlled clinical trial. Clin Oral Investig. 2024 Feb 20;28(2):158. doi: 10.1007/s00784-024-05505-9.

  PMID: 38376596 DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Periodontology

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: December 1, 2016
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: March 15, 2023

Record last verified: 2023-03