Periodontal Pocket
Conditions
Brief summary
Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation.
Interventions
PROCEDUREsubgingival instrumentation
Group B: sites requiring re-treatment are subjected to subgingival scaling
BIOLOGICALsubgingival instrumentation plus Perisolv / hyaDent BG
Group A: Perisolv is applied prior to subgingival instrumentation for disinfecting purpose, hyaDent BG seals the site for accelerated blood clot stabilisation and support of cell proliferation.
Sponsors
University of Witten/Herdecke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* systemically healthy individuals, smokers and non-smokers, HbA1c \<7.5%, compliant and adhering to systematic periodontal treatment protocol incl. SPT visits, patients willing to complete a 9-month post-op observation period
Exclusion criteria
* rheumatoid arthritis, HbA1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level | 9 month post-op | Greater amount of CAL gain in the test group A vs. control group B anticipated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal Probing Depth | 9 months post-op | Greater reduction in PPD for group A vs. Group B anticipated |
| Gingival Recession | 9 months post-op | Similar change in the GR depth anticipated for both groups |
| Bleeding on Probing | 9 months post-op | greater reduction in BOP anticipated for group A vs. group B patients. |
Countries
Germany
Outcome results
None listed