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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.
Research design
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:
Exclusion criteria
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (C): Conventional open flap debridement | Active Comparator | Conventional open flap debridement |
|
| Test group 1 (T1): Open flap debridement using electrolysis decontamination | Experimental | Open flap debridement using (GalvoSurge® - Straumann) |
|
| Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF | Experimental | Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test group 1 (T1) | Procedure | Test group 1 (T1): Open flap debridement using electrolysis decontamination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth | - Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe. | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of plaque, bleeding on probing and suppuration | 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 | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abeer Hakam | Contact | 3053353797 | abeer.hakam@dubaihealth.ac.ae |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25909530 | Background | Hamzacebi B, Oduncuoglu B, Alaaddinoglu EE. Treatment of Peri-implant Bone Defects with Platelet-Rich Fibrin. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):415-22. doi: 10.11607/prd.1861. |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Test group 2 (T2) | Procedure | Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application |
|
| Control group (C) | Procedure | Conventional open flap debridement |
|
| Peri-implant marginal bone level |
- Peri-implant marginal bone level: measured at baseline (prior to surgical intervention), 12 and 24 months using standardized peri-apical radiographs. |
| Baseline (prior to surgical intervention), 12 and 24 months |
| Peri-implant soft tissue level | - Peri-implant soft tissue level: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe. | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months |
| Peri-implant soft tissue thickness (Phenotype) | - 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. | Baseline (prior to surgical intervention), 3, 6, 12 and 24 months |
| D008722 | Methods |