NCT02241577

Brief Summary

This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients presenting with these characteristics will be included at random to one of the treatment groups. Those allocated to the non-surgical group will received implant cleansing after local anesthesia using adequate instruments. In the surgical group, patients will be submitted to a surgical procedure around the implant for visualization and cleansing also after local anesthesia. All patients will be followed over a 12-month period. The hypothesis is that surgical treatment is better than non-surgical treatment regarding clinical, radiographic, microbiological, and immunological.characteristics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

5.2 years

First QC Date

September 12, 2014

Last Update Submit

September 26, 2019

Conditions

Peri-implantitis

Keywords

peri-implantitisdental implantsrandomized controlled trialnon-surgical periodontal treatmentwill be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.

Outcome Measures

Primary Outcomes (1)

  • Pocket depth reduction

    12 months

Secondary Outcomes (6)

  • Clinical attachment level changes

    12 months

  • Alveolar bone level changes

    12 months

  • Subgingival microbiota changes

    12 months

  • Gingival crevicular fluid immune-inflammatory biomarkers

    12 motnhs

  • Serum biomarkers of inflammation

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Surgical treatment

EXPERIMENTAL

Surgical access for scaling and disinfection of dental implant

Procedure: Surgical treatment

Non-surgical treatment

EXPERIMENTAL

Non-surgical subgingival scaling and disinfection of dental implant

Procedure: Non-surgical treatment

Interventions

Surgical treatmentPROCEDURE

Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia

Surgical treatment
Non-surgical treatmentPROCEDURE

Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia

Non-surgical treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with at least one dental implant with peri-implantitits
  • Individuals with good general health conditions;
  • Individuals presenting at least 10 natural teeth;
  • Individuals with no signs of active periodontitis

You may not qualify if:

  • Individuals who received periodontal treatment in the last three months
  • Pregnant
  • Systemic condition that interferes with treatment such as diabetes
  • Individuals who are taking or have taken antibiotics or anti-inflammatory medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alex Haas

Porto Alegre, Rio Grande do Sul, 90630080, Brazil

Location

Related Links

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Cassiano K Rosing, PhD

    Federal University of Rio Grande do Sul

    STUDY CHAIR

  • Joao Augusto P Oliveira, MS

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Tassiane P Wagner, DDS

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Fernando S Rios, MS

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Ricardo SA Costa, MS

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

BR(1)