Interdental Papilla Augmentation Clinical Trial
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
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. 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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment