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PeriodontitisNCT04792541

Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.

A study testing HY containing gel; GUM® Afta Clear Gel, Sunstar and saline solution in people with Periodontitis, run by Malmö University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Periodontitis
What is being tested?
HY containing gel; GUM® Afta Clear Gel, Sunstar and saline solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
No sites listed yet
Study dates
Dec 2016to 8 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • orthodontic treatment
  • class II or III tooth mobility
  • endodontic problem

About this study

Official title: 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.

Read the 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.

Conditions
Periodontitis
Being tested
HY containing gel; GUM® Afta Clear Gel, Sunstar, saline solution
Medical subject headings
Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HY containing gel; GUM® Afta Clear Gel, SunstarOther

  • saline solutionOther

Study groups in NCT04792541
Study groupRoleWhat they receive
control groupPlacebo comparatorsaline solution
Receives: Other: saline solution
test groupExperimentalHY containing gel; GUM® Afta Clear Gel, Sunstar
Receives: Other: HY containing gel; GUM® Afta Clear Gel, Sunstar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. residual periodontal pockets

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study startDec 2016
  3. Primary completion8 Feb 2021
  4. Study completion8 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792541
Sponsor's protocol ID
HY_residual
Status last verified
Mar 2023
First submitted
8 Mar 2021
Last updated
15 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38376596

Questions about this trial

What is this clinical trial studying?

A study testing HY containing gel; GUM® Afta Clear Gel, Sunstar and saline solution in people with Periodontitis, run by Malmö University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

residual periodontal pockets (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792541, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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