Minimally Invasive Volume Augmentation of Papillae Around Implant Restorations With Hyaluronic Acid Injection
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|ClinicalTrials.gov Identifier: NCT02536807|
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Interdental Papilla Augmentation||Drug: Hyaluronan||Not Applicable|
Background Open gingival embrasures, also called "black triangles", may occur after surgical intervention or tooth replacement by an implant. They are perceived as anaesthetic by most patients and causing functional and phonetic problems. Although micro-surgical approaches in oral surgery have considerably improved, reconstruction of a missing papilla to close an open gingival embrasure is still amongst the most challenging surgical scenarios. None of the so far reported surgical interventions are predictable. Recently, injection of hyaluronic acid, an important component of the extracellular matrix, was introduced as a minimally invasive, simple, non-surgical method to augment missing papilla tissue. Yet, controlled clinical studies on the effect of hyaluronic acid to reconstruct a missing papilla are not available so far.
Aim The aim of the present study is to assess the effect of injection of hyaluronic acid for papilla augmentation next to an implant restoration in a clinical controlled double-blinded randomized trial with 6 months follow-up.
Materials and methods Forty patients seeking treatment for open gingival embrasures next to an implant restoration will be included. Patients will be randomly assigned to test group (n=20; injection of hyaluronic acid, Hyadent Barrier Gel, BioScience, Germany; CE certificated for Europe) or control group (n=20; injection of saline solution as a placebo control medium). The following clinical parameters will be assessed at baseline and after 1, 3, and 6 months: Modified papilla index score, distance between papilla tip and contact point, area and volume of black triangle, tissue texture and colour, probing depth, clinical attachment level, presence of plaque and/or bleeding on probing, aesthetic satisfaction of the patient and the examiner and sensation during injection. At baseline and after 6 months the distance between contact point and most cervical region of the alveolar bone crest will be assessed on periapical radiographs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Minimally Invasive Volume Augmentation of Papillae Around Implant Restorations With Hyaluronic Acid Injection. A Randomized Controlled Clinical Trial With 6 Months Follow-up|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Hyaluronan gel injection
HA gel injection
Other Name: HA
Placebo Comparator: Control
Control placebo gel injection
HA gel injection
Other Name: HA
- distance between papilla tip and contact point [ Time Frame: 6 months ]
- Probing pocket depth [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536807
|School of Dentistry, Malmö University|
|Malmö, Sweden, 20506|