Hyaluronan in the Treatment of Residual Pockets in Periodontitis Patients.
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

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.
    

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.
    

Intervention name(s): HY containing gel; GUM® Afta Clear Gel, Sunstar; saline solution
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment