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COMPLETED
NCT07892313
NA

Inflammatory Biomarkers, Microbial Findings, and Clinical Characteristics Before and After Treatment of Peri-Implant Mucositis Around One-Piece and Two-Piece Dental Implants

Sponsor: Cuneyt Asim Aral

View on ClinicalTrials.gov

Summary

The goal of this clinical study was to learn whether the design of a dental implant affects how the gums around it respond to treatment of peri-implant mucositis, an early and reversible inflammation of the soft tissue around a dental implant. The study included systemically healthy, non-smoking adults with one-piece implants (made as a single unit) or two-piece bone-level implants (with a separate connecting part above the implant). The main questions were whether inflammation-related proteins in the fluid around the implant (interleukin-1 beta, interleukin-10, matrix metalloproteinase-8, and tissue inhibitor of metalloproteinases-1), clinical signs of inflammation, and selected bacteria changed differently after treatment around one-piece and two-piece implants. Researchers compared implants with healthy gums and implants with peri-implant mucositis for each implant design, and compared the treatment response of the two designs over 3 months. All participants had a gum and implant examination, including plaque, bleeding, and pocket depth measurements and an assessment of gum thickness around the implant, and gave small samples of fluid and plaque from around the implant using paper strips and paper points. Participants with peri-implant mucositis received professional cleaning of the implant with an ultrasonic device with plastic-capped tips, a single application of chlorhexidine gel, and personal oral hygiene instructions, and returned 1 and 3 months later for repeat examinations and sampling.

Official title: Effects of Periodontal Status and Initial Periodontal Therapy on Peri-Implant Sulcus Fluid Biomarkers in One-Piece and Two-Piece Implant Systems

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2025-01-01

Completion Date

2025-12-01

Last Updated

2026-10-23

Healthy Volunteers

Yes

Interventions

PROCEDURE

Nonsurgical Mechanical Debridement With 1% Chlorhexidine Gel

Ultrasonic mechanical debridement of the implant with polyetheretherketone-capped tips, followed by a single submucosal application of 1% chlorhexidine gel delivered into the peri-implant sulcus with a syringe and a 22-gauge needle, and individualized oral hygiene instructions including the use of interdental brushes.

Locations (1)

Inonu University Faculty of Dentistry

Malatya, Turkey (Türkiye)