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

NCT05201443 | Unknown

• 1 other identifier: KA-19059
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Another outcome of the study is the collection of gingival crevicular fluid samples in the 3rd month.

  Baseline, 3 months and 6 months

• Gingival bleeding time index

  Baseline, 3 months and 6 months

• Gingival index

  Baseline, 3 months and 6 months

• Plaque index

  Baseline, 3 months and 6 months

• Clinical attachment level

  Baseline, 3 months and 6 months

Study Arms (2)

Diode Laser

EXPERIMENTAL

At baseline, diode laser is applied to one group.

Device: Diode laser; Device: Titanium curettes

Titanium curettes

ACTIVE COMPARATOR

At baseline, titanium curettes are used to both of the groups

Device: Titanium curettes

Interventions

Diode laser DEVICE

Diode Laser is applied to one group as an adjunctive therapy.

Diode Laser

Titanium curettes DEVICE

Non-surgical treatment with titanium curettes were administrated to both groups.

Diode Laser; Titanium curettes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Güliz Nigar GÜNCÜ, Prof. Dr.

  study director

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazan Ece ERDURAN

CONTACT

00905541900462; nazaneceerduran@gmail.com

Güliz Nigar Güncü

CONTACT

gngun1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: January 21, 2022
• Study Start: November 12, 2018
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

TU (1)