Clinical trial NCT02241577: Surgical and Non-surgical Treatment of Peri-implantitis
Official title: Surgical and Non-surgical Treatment of Peri-implantitis: Multi-center Randomised Controlled Trial of 12-months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implantitis
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.
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Pocket depth reduction
timeFrame: 12 months
Secondary outcomes:
measure: Clinical attachment level changes
timeFrame: 12 months
measure: Alveolar bone level changes
timeFrame: 12 months
measure: Subgingival microbiota changes
timeFrame: 12 months
measure: Gingival crevicular fluid immune-inflammatory biomarkers
timeFrame: 12 motnhs
measure: Serum biomarkers of inflammation
timeFrame: 12 months
measure: Bleeding on probing
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Alex Haas
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Cassiano K Rosing, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Joao Augusto P Oliveira, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul
name: Tassiane P Wagner, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul
name: Fernando S Rios, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Rio Grande do Sul
name: Ricardo SA Costa, MS
role: PRINCIPAL_INVESTIGATOR
References: