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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02362854
Other study ID # IstanbulU
Secondary ID
Status Completed
Phase N/A
First received September 16, 2014
Last updated February 12, 2015
Start date February 2010
Est. completion date July 2014

Study information

Verified date February 2015
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The aim of this study was to compare the efficacy of a diode laser (DL) as an adjunct to conventional scaling in the treatment of mild-to-moderate peri-implantitis. A prospective clinical, radiographic and microbiologic split-mouth study was conducted to test the following null hypothesis; adjunct application of a diode laser, in the conventional treatment of peri-implantitis, are not associated with a statistically significant difference regarding the microbial counts, marginal bone loss and peri-implant parameters.


Description:

Efficacy of a diode laser (DL) in peri-implantitis was investigated. 48 implants diagnosed with peri-implantitis were included. In addition to the conventional scaling and debridement, random 24 implants were lased by a DL. Periodontal indexes, microbiologic specimens and radiographs were used for assessment. Baseline parameters were similar between groups. After six months laser group revealed higher MBL than the control group. Microbiota of the implants were found unchanged after one month. DL appears to have no additional positive influence on the peri-implantitis treatment.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and older

- No local and systemic health problems prohibit the study interventions

- Bi-lateral implants with peri-implantitis diagnosis

Exclusion Criteria:

- Local and systemic health problems prohibiting the study interventions

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional peri-implantitis treatment
Elimination of the bacterial plaque. Establishing optimal healing conditions. Detoxification of the affected environment.
Device:
DL application in peri-implantitis
Diode laser application in the diseased implants.

Locations

Country Name City State
Turkey Department of Oral Implantology, Faculty of Dentistry, Istanbul University Istanbul Capa

Sponsors (2)

Lead Sponsor Collaborator
Istanbul University Istanbul University Research Fund

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Peri-implant health indexes Bleeding on probing, probing depth and plaque index which determined at the initiation of the study will be re-evaluated after one and six months to asees the effect of the variables one and six months No
Primary Bacterial counts Bacterial load around the the diseased implants will be determined at the initiation of the study. The assessment will be performed after one months One month No
Secondary Marginal Bone loss The marginal bone loss around the diseased implants will be assessed after six months to analyse any bone level change. Six months No
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