NCT02536807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

August 27, 2015

Last Update Submit

September 17, 2016

Conditions

Interdental Papilla Augmentation

Outcome Measures

Primary Outcomes (1)

  • distance between papilla tip and contact point

    6 months

Secondary Outcomes (1)

  • Probing pocket depth

    12 months

Study Arms (2)

Hyaluronan

EXPERIMENTAL

Hyaluronan gel injection

Drug: Hyaluronan

Control

PLACEBO COMPARATOR

Control placebo gel injection

Drug: Hyaluronan

Interventions

HyaluronanDRUG

HA gel injection

Also known as: HA
ControlHyaluronan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Malmö University

Malmo, 20506, Sweden

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Chair, Department of Periodontology

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 1, 2015

Study Start

August 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 20, 2016

Record last verified: 2015-09

Locations

SE(1)