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

September 17, 2016 updated by: Andreas Stavropoulos, Malmö University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20506
        • School of Dentistry, Malmö University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
distance between papilla tip and contact point
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Probing pocket depth
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malmö University

Collaborators

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 17, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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