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

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: Interdental Papilla Augmentation
• Intervention / Treatment: Drug: Hyaluronan

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

2

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	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Probing pocket depth	12 months

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: University of Copenhagen

Study record dates

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: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 42297