ClinicalTrials.gg
Sign In
CompletedNCT02241577Perio-implantsUpdated Oct 1, 2019

Surgical and Non-surgical Treatment of Peri-implantitis

An interventional study of Surgical treatment and Non-surgical treatment in Peri-implantitis, sponsored by Federal University of Rio Grande do Sul. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Peri-implantitis

Browse trials for

Keywords

  • peri-implantitis
  • dental implants
  • randomized controlled trial
  • non-surgical periodontal treatment
  • will be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.
03

In context

Peri-Implantitis

313 studies on the registry are indexed under Peri-Implantitis; 85 are open to participants now.

This study's enrollment of 70 is above the median of 40 across 191 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

Federal University of Rio Grande do Sul is the lead sponsor of 121 studies on the registry; 20 are open to participants now.

Browse Federal University of Rio Grande do Sul studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Surgical treatment

    Surgical access for scaling and disinfection of dental implant

    Procedure: Surgical treatment

  • Experimental
    Non-surgical treatment

    Non-surgical subgingival scaling and disinfection of dental implant

    Procedure: Non-surgical treatment

Interventions

  • ProcedureSurgical treatment

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

  • ProcedureNon-surgical treatment

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

06

What researchers measure

Primary outcomes

  1. Pocket depth reduction

    Time frame: 12 months

Secondary outcomes

  1. Clinical attachment level changes

    Time frame: 12 months

  2. Alveolar bone level changes

    Time frame: 12 months

  3. Subgingival microbiota changes

    Time frame: 12 months

  4. Gingival crevicular fluid immune-inflammatory biomarkers

    Time frame: 12 motnhs

  5. Serum biomarkers of inflammation

    Time frame: 12 months

  6. Bleeding on probing

    Time frame: 12 months

07

Study locations

1 site
  • Alex Haas
    Porto Alegre, Rio Grande do Sul 90630080, Brazil
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Aug 2019 and a completion of Aug 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2014
First posted
Sep 16, 2014
Start
Jun 2014
Primary completionActual
Aug 2019
CompletionActual
Aug 2019
Last update
Oct 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02241577
Lead sponsor
Federal University of Rio Grande do Sul
Responsible party
Alex Nogueira Haas (Associate Professor, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Sep 16, 2014
Start date
Jun 2014
Primary completion
Aug 2019
Completion
Aug 2019
Last update
Oct 1, 2019

Study contacts

Cassiano K Rosing, PhD
study chair · Federal University of Rio Grande do Sul
Joao Augusto P Oliveira, MS
principal investigator · Federal University of Rio Grande do Sul
Tassiane P Wagner, DDS
principal investigator · Federal University of Rio Grande do Sul
Fernando S Rios, MS
principal investigator · Federal University of Rio Grande do Sul
Ricardo SA Costa, MS
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peri-Implantitis →

Other studies from this sponsor

Federal University of Rio Grande do Sul →

Start the discussion