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.
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 group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | saline solution Receives: Other: saline solution |
| test group | Experimental | HY 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.
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.
- First posted11 Mar 2021
- Study startDec 2016
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Stavropoulos, Malmö University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04792541
- Acronym / sponsor ID
- HY_residual
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: saline solutionsaline solution |
| test group | Experimental | Other: HY containing gel; GUM® Afta Clear Gel, SunstarHY containing gel; GUM® Afta Clear Gel, Sunstar |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HY containing gel; GUM® Afta Clear Gel, Sunstar | Other | test group |
| saline solution | Other | control group |
Primary outcome
residual periodontal pockets
Time frame: 12 months
number of experimental sites showing PD < 5 mm or no PD ≥ 5 mm + BoP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 38376596Bertl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.