Peri-Implantitis Clinical Trial
— RASOfficial title:
Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin: A 6-month Randomized Controlled Clinical Trial
Verified date | September 2020 |
Source | October 6 University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to evaluate the effect of using a synthetic bone substitute with or
without simvastatin on regenerative surgical treatment of bone defects associated with
peri-implantitis in a 6- months randomized controlled clinical trial.
A total of 30 patients diagnosed with peri-implantitis were randomly assigned to one of two
surgical treatment groups (group I: synthetic bone substitute (NanoBone), group II: NanoBone
with simvastatin). Clinical measurements included probing pocket depth (PPD), clinical
attachment level (CAL), plaque index (PI), modified sulcus bleeding index (mSBI) and mucosal
recession (MR). Radiographic bone fill was evaluated at baseline and after 6- months.
Status | Completed |
Enrollment | 36 |
Est. completion date | August 15, 2020 |
Est. primary completion date | June 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. age > 18 years, 2. having at least one implant demonstrating bone defect =3 mm, which presented a probing depth of =5 mm with BOP and/or suppuration, implants had to be in function for >12 months, 3. no implant mobility and no evidence of occlusal overload, 4. no evidence of occlusal overload 5. presence of at least 2 mm of keratinized attached mucosa . Exclusion Criteria: 1. serious systemic diseases, medications or conditions that would contraindicate periodontal surgery and compromise wound healing, 2. history of taking systemic antibiotic during the past 3 months, 3. smoking, 4. pregnant or lactating females, 5. implants previously augmented with bone substitute or placed in grafted bone, 6. implants previously treated for peri-implantitis, 7. a mobile implant. |
Country | Name | City | State |
---|---|---|---|
Egypt | October 6 University | El-Sheikh Zayed City | Giza |
Lead Sponsor | Collaborator |
---|---|
Reham Lotfy Aggour | October 6 University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical attachment level (CAL) | Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession | 6 months | |
Secondary | probing pocket depth | measured as the distance from the mucosal margin to the base of the deepest pocket of the implant | 6 months | |
Secondary | plaque index (PI) | marked with a score from 0 to 3. Grade 0: no plaque; Grade 1: plaques could be found on the surface of the implant after scratching with the probe tip gently; Grade 2: plaque could be seen by the naked eye; and Grade 3: a large amount of plaques could be seen | 6 months | |
Secondary | Bleeding on probing (BoP) | modified sulcus bleeding index (mSBI) . This index scores the bleeding on a zero to three scale, where 0: no bleeding, 1: isolated bleeding spots, 2: blood forms a confluent red line and 3: heavy or profuse bleeding. | 6 months | |
Secondary | Mucosal recession (MR) | measured as the distance from the mucosal margin and the implant abutment interface | 6 months | |
Secondary | The change in bone level (BL) | the distance (mm) between the implant shoulder and the bottom of the defect | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05332327 -
Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
|
||
Enrolling by invitation |
NCT06063876 -
Experimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty
|
N/A | |
Completed |
NCT04249024 -
Peri-implantitis, Comparing Treatments 970 nm Laser and Mucosal Flap Surgery
|
N/A | |
Withdrawn |
NCT03624257 -
Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery
|
N/A | |
Completed |
NCT02375750 -
Treatment of Peri-implantitis Lesions by Using Biomaterial
|
N/A | |
Completed |
NCT03157193 -
Effect of Hyaluronic Acid on Perimplantitis
|
Phase 4 | |
Completed |
NCT03018795 -
Ozone Therapy as an Adjunct to the Surgical Treatment of Peri-implantitis
|
N/A | |
Enrolling by invitation |
NCT02575274 -
Peri-Implantitis Surgical Treatment an RCT Study
|
Phase 2/Phase 3 | |
Completed |
NCT04833569 -
ICG-PDT, Periimplantitis, Diabetes Mellitus
|
Phase 1 | |
Not yet recruiting |
NCT04337645 -
Resective Surgical Treatment of Peri-implantitis.
|
N/A | |
Enrolling by invitation |
NCT06033859 -
Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression
|
||
Active, not recruiting |
NCT06390124 -
Reconstructive Therapy of Peri-implantitis With PDGF-BB (Gem-21)
|
Phase 4 | |
Enrolling by invitation |
NCT05675241 -
Characterizing the Inflammation Around Dental Implants
|
||
Recruiting |
NCT04983758 -
20-year Implant Survival in Periodontally Healthy and Compromised Patients
|
||
Completed |
NCT04769609 -
Reconstructive Surgical Therapy of Peri-implantitis
|
||
Completed |
NCT04874467 -
Influence of Keratinized Mucosa on Dental Implants With Mucositis
|
N/A | |
Not yet recruiting |
NCT04323540 -
Treatment of Peri-implantitis With or Without Simultaneous Soft Tissue Augmentation
|
N/A | |
Completed |
NCT05724706 -
An Evaluation of Salivary Oxidant and Antioxidant Levels in Peri-implant Health and Disease
|
||
Recruiting |
NCT05906810 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis
|
N/A | |
Completed |
NCT05595746 -
Radiological Bone Loss on Different Levels of Dental Implants
|
N/A |