A Phase 4 interventional study of subgingival instrumentation plus Perisolv / hyaDent BG and subgingival instrumentation in Periodontal Pocket, sponsored by University of Witten/Herdecke. Completed at 1 site in Germany. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by University of Witten/Herdecke · Phase 4, Interventional, and Treatment
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.
130 studies on the registry are indexed under Periodontal Pocket; 35 are open to participants now.
This study's enrollment of 52 is above the median of 30 across 113 interventional studies indexed under Periodontal Pocket.
Browse Periodontal Pocket studies →University of Witten/Herdecke is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Test arm, patients undergo subgingival instrumentation of residual active site together with an adjunctive treatment protocol.
Biological: subgingival instrumentation plus Perisolv / hyaDent BG
Control arm, patients undergo subgingival instrumentation of residual active site only.
Procedure: subgingival instrumentation
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.
Group B: sites requiring re-treatment are subjected to subgingival scaling
Clinical Attachment Level
Greater amount of CAL gain in the test group A vs. control group B anticipated
Time frame: 9 month post-op
Periodontal Probing Depth
Greater reduction in PPD for group A vs. Group B anticipated
Time frame: 9 months post-op
Gingival Recession
Similar change in the GR depth anticipated for both groups
Time frame: 9 months post-op
Bleeding on Probing
greater reduction in BOP anticipated for group A vs. group B patients.
Time frame: 9 months post-op
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Witten/Herdecke