NCT02362854

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

4.4 years

First QC Date

September 16, 2014

Last Update Submit

February 12, 2015

Conditions

Keywords

dental implantlaserdiode laserperi-implantitisbacterial count

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Marginal Bone loss

    Six months

Other Outcomes (1)

  • Peri-implant health indexes

    one and six months

Study Arms (2)

Conventional peri-implantitis treatment

ACTIVE COMPARATOR

Peri-implantitis treatment according to the Cumulative interceptive supportive (CIST) therapy.

Procedure: Conventional peri-implantitis treatment

DL application in peri-implantitis

EXPERIMENTAL

Adjunct Diode Laser application.

Device: DL application in peri-implantitis

Interventions

Elimination of the bacterial plaque. Establishing optimal healing conditions. Detoxification of the affected environment.

Also known as: CIST treatment protocol
Conventional peri-implantitis treatment

Diode laser application in the diseased implants.

DL application in peri-implantitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • No local and systemic health problems prohibit the study interventions
  • Bi-lateral implants with peri-implantitis diagnosis

You may not qualify if:

  • Local and systemic health problems prohibiting the study interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral Implantology, Faculty of Dentistry, Istanbul University

Istanbul, Capa, 34093, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Peri-ImplantitisAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Study Officials

  • Volkan Arısan, Ass.Prof.Dr.

    Istanbul University, Faculty of Dentistry

    STUDY CHAIR
  • Cuneyt Karabuda, Prof.Dr.

    Istanbul University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.Dr

Study Record Dates

First Submitted

September 16, 2014

First Posted

February 13, 2015

Study Start

February 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations