Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
Primary Purpose
Peri-Implantitis
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diode laser
Titanium curettes
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis
Eligibility Criteria
Inclusion Criteria:
- Presence of 5mm or more peri-implant pockets
- Not having periodontal treatment in the last 3 months,
- The informed consent form must be approved,
- At least 18 years old.
Exclusion Criteria:
- Presence of systemic disease,
- Smoking,
- Regular use of non-steroidal anti inflammatory drugs,
- Having been treated with antibiotics in the last 3 months,
- Individuals in need of pre-treatment antibiotic prophylaxis,
- Pregnancy and lactation,
- Not approving the informed consent form,
- Patients with known allergies.
Sites / Locations
- Hacettepe UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diode Laser
Titanium curettes
Arm Description
At baseline, diode laser is applied to one group.
At baseline, titanium curettes are used to both of the groups
Outcomes
Primary Outcome Measures
Clinical parameter probing depth
The primary outcome of the study was the control examination performed 3 months after the first examination. Probing depth was measured with a periodontal probe by the distance between gingival margin and the base of the pocket. The change between these time frames are recorded.
Secondary Outcome Measures
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
Samples are obtained by means of paper strips placed gently in the gingival groove. These samples are stored at -20 ° C for later analysis by ELISA method. The change between these time frames are recorded.
Gingival bleeding time index
Bleeding on probing according to the time is recorded. The change between these time frames are recorded.
Gingival index
The gingival index is graded as follows:
0 = Normal gingiva
Mild inflammation, slight change in color, slight oedema. No bleeding on probing
Moderate inflammation redness, oedema and glazing. Bleeding on probing
Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Plaque index
0 = No plaque in the gingival area.
A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Clinical attachment level
The distance in millimeters from the cemento-enamel junction to the bottom of the pocket.
Full Information
NCT ID
NCT05201443
First Posted
October 12, 2021
Last Updated
February 11, 2022
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT05201443
Brief Title
Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
Official Title
Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Peri-implantitis is a pathological condition associated with plaque that develops around dental implants, characterized by inflammation and progressive bone loss in the peri-implant area. Bleeding on probing, suppuration, increased pathological pocket depths and/or mucosal recessions are seen with radiographic bone loss in peri-implantitis. When evaluated histologically, the lesion extends to the apical part of the pocket epithelium and contains a large amount of plasma cells, macrophages and neutrophils. In the Peri-implant crevicular fluid analysis, which is one of the most important parameters that enable the biochemical and immunological evaluation of the inflammatory state in the peri-implant region, information about the current inflammatory situation can be obtained by evaluating the content of an osmotic inflammatory exudate originating from the vessels in the gingival plexus. Many surgical and non-surgical methods have been proposed for the treatment of peri-implantitis. Mechanical surface debridement, laser application and air abrasives are a part of non-surgical treatment of peri-implantitis. In this study, we examined the effectiveness of diode laser in addition to mechanical debridement with titanium curettes. In our study, we aimed to compare these two treatments biochemically by determining the changes in interleukin-1β, Interleukin-10, Interleukin-17, RANKL, osteoprotegerin, TWEAK and sclerostin biomarkers in Peri-implant crevicular fluid and clinically.
Detailed Description
Primary outcome measures (probing depth as clinical parameter) and secondary outcome measures ( collection of gingival crevicular fluid, gingival bleeding time index, gingival index, plaque index and clinical attachment level) asre recorded in baseline, third and sixth month. The change between these parameters is observed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diode Laser
Arm Type
Experimental
Arm Description
At baseline, diode laser is applied to one group.
Arm Title
Titanium curettes
Arm Type
Active Comparator
Arm Description
At baseline, titanium curettes are used to both of the groups
Intervention Type
Device
Intervention Name(s)
Diode laser
Intervention Description
Diode Laser is applied to one group as an adjunctive therapy.
Intervention Type
Device
Intervention Name(s)
Titanium curettes
Intervention Description
Non-surgical treatment with titanium curettes were administrated to both groups.
Primary Outcome Measure Information:
Title
Clinical parameter probing depth
Description
The primary outcome of the study was the control examination performed 3 months after the first examination. Probing depth was measured with a periodontal probe by the distance between gingival margin and the base of the pocket. The change between these time frames are recorded.
Time Frame
Baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.
Description
Samples are obtained by means of paper strips placed gently in the gingival groove. These samples are stored at -20 ° C for later analysis by ELISA method. The change between these time frames are recorded.
Time Frame
Baseline, 3 months and 6 months
Title
Gingival bleeding time index
Description
Bleeding on probing according to the time is recorded. The change between these time frames are recorded.
Time Frame
Baseline, 3 months and 6 months
Title
Gingival index
Description
The gingival index is graded as follows:
0 = Normal gingiva
Mild inflammation, slight change in color, slight oedema. No bleeding on probing
Moderate inflammation redness, oedema and glazing. Bleeding on probing
Severe inflammation marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Time Frame
Baseline, 3 months and 6 months
Title
Plaque index
Description
0 = No plaque in the gingival area.
A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Time Frame
Baseline, 3 months and 6 months
Title
Clinical attachment level
Description
The distance in millimeters from the cemento-enamel junction to the bottom of the pocket.
Time Frame
Baseline, 3 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presence of 5mm or more peri-implant pockets
Not having periodontal treatment in the last 3 months,
The informed consent form must be approved,
At least 18 years old.
Exclusion Criteria:
Presence of systemic disease,
Smoking,
Regular use of non-steroidal anti inflammatory drugs,
Having been treated with antibiotics in the last 3 months,
Individuals in need of pre-treatment antibiotic prophylaxis,
Pregnancy and lactation,
Not approving the informed consent form,
Patients with known allergies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nazan Ece ERDURAN
Phone
00905541900462
Email
nazaneceerduran@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Güliz Nigar Güncü
Email
gngun1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Güliz Nigar GÜNCÜ, Prof. Dr.
Organizational Affiliation
study director
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdullah Cevdet AKMAN, Prof Dr
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rahime Meral NOHUTCU
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Tuğrul GÜR, Phd
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aslı PINAR, Prof Dr
Organizational Affiliation
biochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nazan Ece Erduran
12. IPD Sharing Statement
Learn more about this trial
Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis
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