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Minimally Invasive Volume Augmentation of Papillae Around Implant Restorations With Hyaluronic Acid Injection

Sponsor
Malmö University (Other)
Overall Status
Completed
CT.gov ID
NCT02536807
Collaborator
University of Copenhagen (Other)
22
Enrollment
1
Location
2
Arms
21
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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.

Study Design

Study Type:
Interventional
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 :
Aug 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hyaluronan

Hyaluronan gel injection

Drug: Hyaluronan
HA gel injection
Other Names:
  • HA

    		•
    Placebo Comparator: Control

    Control placebo gel injection

    Drug: Hyaluronan
    HA gel injection
    Other Names:
  • HA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. distance between papilla tip and contact point [6 months]

    Secondary Outcome Measures

    1. Probing pocket depth [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Dentistry, Malmö University Malmö Sweden 20506

    Sponsors and Collaborators

    • Malmö University
    • University of Copenhagen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andreas Stavropoulos, Professor & Chair, Department of Periodontology, Malmö University
    ClinicalTrials.gov Identifier:
    NCT02536807
    Other Study ID Numbers:
    • 42297
    First Posted:
    Sep 1, 2015
    Last Update Posted:
    Sep 20, 2016
    Last Verified:
    Sep 1, 2015
    Additional relevant MeSH terms:
    Hyaluronic Acid

    Study Results

    No Results Posted as of Sep 20, 2016