NCT03157193

Brief Summary

The effect of the hyaluronic acid treatment on peri-implantitis has not been tested. The aim was to analyze the effect of a hyaluronic acid-containing gel on the clinical variables and the expression of biochemical inflammatory markers in the crevicular fluid of implants receiving perimplantitis treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2014

Typical duration for phase_4

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

September 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

May 15, 2017

Last Update Submit

May 16, 2017

Conditions

Peri-Implantitis

Keywords

Peri-ImplantitisDental ImplantsHyaluronic AcidClinical Trial

Outcome Measures

Primary Outcomes (5)

  • Peri-implant probing depth

    Probing depth (mm) assessed by periodontal probe.

    Baseline, change at 45 days and at 90 days.

  • Peri-implant attachment level

    Probing attachment level (mm) calculated using probing depth and exposed implant threads.

    Baseline, change at 45 days and at 90 days.

  • Peri-implant bleeding

    Bleeding on probing expressed as % of bleeding implants in each group.

    Baseline, change at 45 days and at 90 days.

  • Marginal Bone level

    Alveolar bone level assesed in periapical digital radiographs by image processing software (ImageJ).

    Baseline, change at 45 days and at 90 days.

  • Peri-implant crevicular fluid cytokines.

    Inflammatory cytokines (IL1B and TNFa) measured in Peri-implant crevicular fluid by ELISA.

    Baseline and change at 45 days.

Study Arms (3)

Test Group

EXPERIMENTAL

Hyaluronic acid gel 0.2% at baseline and later home applications by the patients during 45 days.

Drug: Hyaluronic Acid

Control 1 Group

SHAM COMPARATOR

Hydroxypropyl guar based gel, without any biological effect.

Drug: Hydroxypropyl Guar

Control 2 Group

NO INTERVENTION

No gel application, only standard perimplantitis treatment.

Interventions

Hyaluronic AcidDRUG

Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.

Also known as: HA
Test Group
Hydroxypropyl GuarDRUG

Hydroxypropyl Guar gel application as sham comparator

Also known as: Control 1
Control 1 Group

Eligibility Criteria

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

You may qualify if:

  • Implants with at least one year of functional load.
  • Implants diagnosed with peri-implantitis according to the criteria of the Association of Dental Implantology.

You may not qualify if:

  • Previous peri-implantitis treatment.
  • Pregnancy or breast-feeding.
  • Neoplastic disease.
  • Antibiotic treatment during the previous month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sanchez-Fernandez E, Magan-Fernandez A, O'Valle F, Bravo M, Mesa F. Hyaluronic acid reduces inflammation and crevicular fluid IL-1beta concentrations in peri-implantitis: a randomized controlled clinical trial. J Periodontal Implant Sci. 2021 Feb;51(1):63-74. doi: 10.5051/jpis.1903660183.

    PMID: 33634616DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Hyaluronic Acidhydroxypropyl guar

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Periodontology

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share