coronally advanced flap
Procedurecoronally advanced flap alone (CAF- control)
NCT Number: NCT03204565
The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) in combination with the coronally advanced flap (CAF) for the treatment of single gingival recession site.
The hypothesis is that HA will result in improved the clinical outcomes and will reduce the pos-operative morbidity
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Gingival recession is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Buccal exposure of roots with aesthetic impairments and dentinal hypersensitivity The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an aesthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths.Several surgical techniques have already provided good results and have been shown to attain root coverage at individual recession sites these different methods.To date, connective tissue grafts (CTG) and enamel matrix derivatives (EMD) in conjunction with a coronally advanced flap (CAF) have been shown to provide the highest probability of obtaining complete root coverage (CRC) in Miller class I and II single gingival recession as compared to CAF alone.
Hyaluronic acid (HA) is a major component of the extracellular matrix in almost all tissues. The primary role of HA is to bind water and to permit the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues.
In vitro and animal studies have demonstrated that hyaluronic acid have many properties that are essential for tissue regeneration and wound healing.
However, to the best of our knowledge, there have been limited clinical application studies in the field of root coverage procedures performed and still no consistent published data with longer follow-ups on the usage of HA are available.
Therefore, the aim of this randomized controlled clinical trial (RCT) was to evaluate the potential benefit of the adjunctive use of HA in combination with a coronally advanced flap (CAF) and to compare the outcomes with CAF alone, when treating single Miller Class I gingival recessions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
coronally advanced flap alone (CAF- control)
hyaluronic acid associated to coronally advanced flap (CAF + HA- test)
Time frame: baseline and 18 months
Changes in recession depth between initial and final. Measured in mm
Time frame: 7 days
With an evaluation questionnaire. The interviewer assessed patient's pain, swelling and discomfort at 7 days after procedure using visual analogue scale (VAS) ranging from 0 (no pain/swelling/discomfort) to 10 (maximal pain/swelling/discomfort).
Time frame: 18 months
Assessed as percentage of sites with complete root coverage
Time frame: 18 months
Assessed as percentage of mean root coverage for each group.
Time frame: baseline and 18 months
Changes in PPD between initial and final. Measured in mm
Time frame: baseline and 18 months
Difference between CAL initial and final. Measured in mm
Time frame: baseline and 18 months
Changes in KT between initial and final. Measured in mm
University of Roma La Sapienza
Other
Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Miller Class I Single Gingival Recession Sites
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