Peri Implantitis
Conditions
Brief summary
The aim of this study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system. And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis.
Detailed description
Research design * Prospective, in which participants will be recruited and then followed up throughout a specified period of time. * Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups. * Single-blinded as the outcome accessors will be blinded to the intervention. Materials and Methods: Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria: Inclusion criteria: * Aged 18 or over. * Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling). * Screw retained implant crown. * Good compliance and commitment to attend follow-up review appointments. * Willing to provide informed consent. Exclusion criteria * History of surgical therapy of peri-implantitis. * Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect). * Cement retained implant crown. * Systemic/local antibiotics during the previous 6 months. * Bone metabolic disease and/or taking medications that affect bone metabolism. * History of malignancy, radiotherapy or chemotherapy. * Pregnant or lactating women. * Smokers The study will be conducted following the ethical standards of the Declaration of Helsinki in 1975, as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study. Randomization, allocation concealment and blinding: The participants will be randomly allocated to three equally sized groups using computer-generated numbers: Control group (C): Conventional open flap debridement Test group 1 (T1): Open flap debridement using (GalvoSurge® - Straumann) Test group 2 (T2): Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application
Interventions
PROCEDURETest group 1 (T1)
Test group 1 (T1): Open flap debridement using electrolysis decontamination
PROCEDURETest group 2 (T2)
Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application
PROCEDUREControl group (C)
Conventional open flap debridement
Sponsors
Abeer Hakam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 or over. * Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling). * Screw retained implant crown. * Good compliance and commitment to attend follow-up review appointments. * Willing to provide informed consent.
Exclusion criteria
* History of surgical therapy of peri-implantitis. * Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect). * Cement retained implant crown. * Systemic/local antibiotics during the previous 6 months. * Bone metabolic disease and/or taking medications that affect bone metabolism. * History of malignancy, radiotherapy or chemotherapy. * Pregnant or lactating women. * Smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months | \- Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of plaque, bleeding on probing and suppuration | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months | Presence or absence of plaque, bleeding on probing and suppuration: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe |
| Peri-implant marginal bone level | Baseline (prior to surgical intervention), 12 and 24 months | \- Peri-implant marginal bone level: measured at baseline (prior to surgical intervention), 12 and 24 months using standardized peri-apical radiographs. |
| Peri-implant soft tissue level | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months | \- Peri-implant soft tissue level: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe. |
| Peri-implant soft tissue thickness (Phenotype) | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months | \- Peri-implant soft tissue thickness (Phenotype): measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using an endodontic spreader at 3 points. |
Contacts
Primary ContactAbeer Hakam
Outcome results
None listed