Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04792541 |
| Other study ID # |
HY_residual |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
February 8, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
Malmö University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
