Clinical and Biochemical Evaluation of the Efficacy of Non-Surgical Treatment Approaches in the Treatment of Peri-implantitis

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.

Study Overview

• Status: Recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: Device: Diode laser; Device: Titanium curettes

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.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nazan Ece ERDURAN; Phone Number: 00905541900462; Email: nazaneceerduran@gmail.com
• Study Contact Backup: Name: Güliz Nigar Güncü; Email: gngun1@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Hacettepe University
    • Contact: Nazan Ece Erduran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diode Laser; At baseline, diode laser is applied to one group.	Device: Diode laser; Diode Laser is applied to one group as an adjunctive therapy.; Device: Titanium curettes; Non-surgical treatment with titanium curettes were administrated to both groups.
Active Comparator: Titanium curettes; At baseline, titanium curettes are used to both of the groups	Device: Titanium curettes; Non-surgical treatment with titanium curettes were administrated to both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3 months and 6 months
Gingival bleeding time index	Bleeding on probing according to the time is recorded. The change between these time frames are recorded.	Baseline, 3 months and 6 months
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.	Baseline, 3 months and 6 months
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.	Baseline, 3 months and 6 months
Clinical attachment level	The distance in millimeters from the cemento-enamel junction to the bottom of the pocket.	Baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Güliz Nigar GÜNCÜ, Prof. Dr., Study Director; Principal Investigator: Abdullah Cevdet AKMAN, Prof Dr, Principal Investigator; Principal Investigator: Rahime Meral NOHUTCU, Principal Investigator; Principal Investigator: Ali Tuğrul GÜR, Phd, Principal Investigator; Principal Investigator: Aslı PINAR, Prof Dr, biochemistry

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: KA-19059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No