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Trial record 1 of 1 for:    NCT02536807
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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
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Andreas Stavropoulos, Malmö University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Interdental Papilla Augmentation Drug: Hyaluronan Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyaluronan
Hyaluronan gel injection
Drug: Hyaluronan
HA gel injection
Other Name: HA

Placebo Comparator: Control
Control placebo gel injection
Drug: Hyaluronan
HA gel injection
Other Name: HA




Primary Outcome Measures :
  1. distance between papilla tip and contact point [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Probing pocket depth [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • atrophic papillae in the maxilla or mandible anteriorly to 1st premolar next to an implant
  • at least 18 years of age and adequate plaque control (full mouth plaque score < 20%)

Exclusion Criteria:

  • open contact point, positive bleeding on probing and/or probing depth >5mm,
  • presence of a labial recession (depth >3mm) at the neighboring teeth
  • <2mm keratinized tissue at the gingival margin of the neighboring teeth/implant
  • known systemic healing disorders (e.g. uncontrolled diabetes, malignancy, disease affecting connective tissue metabolism)
  • regular intake of medications with an effect on mucosal healing (e.g. steroids)
  • pregnancy or breast-feeding

Information from the National Library of Medicine

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


Locations
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Sweden
School of Dentistry, Malmö University
Malmö, Sweden, 20506
Sponsors and Collaborators
Malmö University
University of Copenhagen

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Responsible Party: Andreas Stavropoulos, Professor & Chair, Department of Periodontology, Malmö University
ClinicalTrials.gov Identifier: NCT02536807     History of Changes
Other Study ID Numbers: 42297
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2015

Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents