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

NCT07892313 | Completed

• 1 other identifier: IUCREC.2024.181
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

One-Piece Dental Implant; Bone-Level Implant; Two-Piece Dental Implant; Nonsurgical Mechanical Debridement; Chlorhexidine Gel; Soft Tissue Phenotype; Peri-Implant Conditions; Peri-Implant Mucositis; Microbiology

Keywords

One-Piece Dental Implant; Bone-Level Implant; Two-Piece Dental Implant; Implant-Abutment Interface; Peri-Implant Sulcus Fluid; Interleukin-1beta; Interleukin-10; Matrix Metalloproteinase 8; Tissue Inhibitor of Metalloproteinase-1; Nonsurgical Mechanical Debridement; Chlorhexidine Gel; Porphyromonas gingivalis; Fusobacterium nucleatum; Treponema denticola; Filifactor alocis; Soft Tissue Phenotype

Outcome Measures

Primary Outcomes (1)

• Change in Peri-Implant Sulcus Fluid Interleukin-1 Beta (IL-1β) Total Amount

  Total amount of IL-1β in peri-implant sulcus fluid (pg per implant, two pooled paper strips each collected for 30 s), measured by enzyme-linked immunosorbent assay (ELISA). Changes from baseline were compared between one-piece and two-piece bone-level implants with peri-implant mucositis. Baseline values were also compared between implants with peri-implant health and peri-implant mucositis of both designs.

  Baseline, 1 month, and 3 months after treatment

Secondary Outcomes (16)

• Change in Peri-Implant Sulcus Fluid Interleukin-10 (IL-10) Total Amount

  Baseline, 1 month, and 3 months after treatment

• Change in Peri-Implant Sulcus Fluid Matrix Metalloproteinase-8 (MMP-8) Total Amount

  Baseline, 1 month, and 3 months after treatment

• Change in Peri-Implant Sulcus Fluid Tissue Inhibitor of Metalloproteinases-1 (TIMP-1) Total Amount

  Baseline, 1 month, and 3 months after treatment

• Change in Peri-Implant Sulcus Fluid IL-1β/IL-10 Ratio

  Baseline, 1 month, and 3 months after treatment

• Change in Peri-Implant Sulcus Fluid MMP-8/TIMP-1 Ratio

  Baseline, 1 month, and 3 months after treatment

Study Arms (4)

Two-Piece Bone-Level Implants With Peri-Implant Mucositis (BL-PM)

EXPERIMENTAL

Two-piece bone-level implants diagnosed with peri-implant mucositis received nonsurgical therapy and were re-examined and re-sampled 1 and 3 months after treatment.

Procedure: Nonsurgical Mechanical Debridement With 1% Chlorhexidine Gel

One-Piece Implants With Peri-Implant Mucositis (1P-PM)

EXPERIMENTAL

One-piece implants diagnosed with peri-implant mucositis received nonsurgical therapy and were re-examined and re-sampled 1 and 3 months after treatment.

Procedure: Nonsurgical Mechanical Debridement With 1% Chlorhexidine Gel

Two-Piece Bone-Level Implants With Peri-Implant Health (BL-H)

NO INTERVENTION

Two-piece bone-level implants with peri-implant health. No treatment was given, and clinical, biochemical, and microbiological data were collected at baseline only for cross-sectional comparison.

One-Piece Implants With Peri-Implant Health (1P-H)

NO INTERVENTION

One-piece implants with peri-implant health. No treatment was given, and clinical, biochemical, and microbiological data were collected at baseline only for cross-sectional comparison.

Interventions

Nonsurgical Mechanical Debridement With 1% Chlorhexidine Gel PROCEDURE

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.

Also known as: Nonsurgical peri-implant mucositis therapy

One-Piece Implants With Peri-Implant Mucositis (1P-PM); Two-Piece Bone-Level Implants With Peri-Implant Mucositis (BL-PM)

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Systemically healthy
• Non-smoker
• At least one one-piece implant (Monoimplant Rough B, Novodent SA) or two-piece bone-level implant (Implantswiss, Novodent SA) restored and in function
• Probing depth of 5 mm or less, no suppuration, and no clinical mobility at the study implant
• For the peri-implant health groups: absence of clinical signs of inflammation and of bleeding or suppuration on gentle probing, no radiographic bone loss beyond initial remodeling, and a full-mouth bleeding score below 10%
• For the peri-implant mucositis groups: clinical signs of inflammation and bleeding on gentle probing, no radiographic bone loss beyond initial remodeling, and a full-mouth bleeding score of 10% or more
• Written informed consent

You may not qualify if:

• Systemic disease
• Immune disorders or use of immunosuppressive medication
• Need for antibiotic prophylaxis before dental procedures
• Bisphosphonate therapy
• Pregnancy or lactation
• Smoking or alcohol consumption
• Antibiotic use within the previous 6 months
• Continuous systemic medication
• Implants in function for less than 6 months after prosthetic restoration

Sponsors & Collaborators

• Cuneyt Asim Aral: lead
• University of Turku: collaborator
• Harvard School of Dental Medicine: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, 44210, Turkey (Türkiye)

Location

Related Publications (10)

• Feng Z, Zhu J, Zhang L, Li C, Su D, Wang H, Yu Y, Song L. Microbiological and functional traits of peri-implant mucositis and correlation with disease severity. mSphere. 2024 Jul 30;9(7):e0005924. doi: 10.1128/msphere.00059-24. Epub 2024 Jul 9.

  PMID: 38980075 BACKGROUND

• Sun F, Wei Y, Li S, Nie Y, Wang C, Hu W. Shift in the submucosal microbiome of diseased peri-implant sites after non-surgical mechanical debridement treatment. Front Cell Infect Microbiol. 2023 Jan 16;12:1091938. doi: 10.3389/fcimb.2022.1091938. eCollection 2022.

  PMID: 36726642 BACKGROUND

• Cota K, Meto A, Fiorillo L, Galletti C, Fraile JF, Meto A. Implant-Abutment Interface and Peri-implant Inflammation in One-Piece and Two-Piece Dental Implants: A Narrative Review. Eur J Dent. 2026 Jun 17. doi: 10.1055/s-0046-1824451. Online ahead of print.

  PMID: 42309165 BACKGROUND

• Jervoe-Storm PM, Jepsen S, Johren P, Mericske-Stern R, Enkling N. Internal bacterial colonization of implants: association with peri-implant bone loss. Clin Oral Implants Res. 2015 Aug;26(8):957-963. doi: 10.1111/clr.12421. Epub 2014 May 26.

  PMID: 24861845 BACKGROUND

• Renvert S, Polyzois IN. Clinical approaches to treat peri-implant mucositis and peri-implantitis. Periodontol 2000. 2015 Jun;68(1):369-404. doi: 10.1111/prd.12069.

  PMID: 25867993 BACKGROUND

• Isola G, Polizzi A, Santagati M, Alibrandi A, Iorio-Siciliano V, Ramaglia L. Effect of Nonsurgical Mechanical Debridement With or Without Chlorhexidine Formulations in the Treatment of Peri-Implant Mucositis. A Randomized Placebo-Controlled Clinical Trial. Clin Oral Implants Res. 2025 May;36(5):566-577. doi: 10.1111/clr.14405. Epub 2025 Jan 25.

  PMID: 39865359 BACKGROUND

• Goncalves LTDC, Neves GST, da Silva AMP, Telles DM, Figueredo CMDS, Lourenco EJV, Teixeira MKS. The Effect of Peri-Implant Therapy on the Expression of Th17-Related Cytokines in Patients with Peri-Implant Mucositis and Peri-Implantitis: A Prospective Longitudinal Study. J Clin Med. 2025 Jan 8;14(2):340. doi: 10.3390/jcm14020340.

  PMID: 39860346 BACKGROUND

• Severino VO, Beghini M, de Araujo MF, de Melo MLR, Miguel CB, Rodrigues WF, de Lima Pereira SA. Expression of IL-6, IL-10, IL-17 and IL-33 in the peri-implant crevicular fluid of patients with peri-implant mucositis and peri-implantitis. Arch Oral Biol. 2016 Dec;72:194-199. doi: 10.1016/j.archoralbio.2016.08.021. Epub 2016 Aug 24.

  PMID: 27608364 BACKGROUND

• Arakawa H, Uehara J, Hara ES, Sonoyama W, Kimura A, Kanyama M, Matsuka Y, Kuboki T. Matrix metalloproteinase-8 is the major potential collagenase in active peri-implantitis. J Prosthodont Res. 2012 Oct;56(4):249-55. doi: 10.1016/j.jpor.2012.07.002. Epub 2012 Oct 18.

  PMID: 23083963 BACKGROUND

• Kao RT, Curtis DA, Richards DW, Preble J. Increased interleukin-1 beta in the crevicular fluid of diseased implants. Int J Oral Maxillofac Implants. 1995 Nov-Dec;10(6):696-701.

  PMID: 8530172 BACKGROUND

Study Officials

• Cüneyt A Aral, Chair, Professor, DDS, PhD

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Periodontology, Inonu University Faculty of Dentistry

Model Details: Implants were assigned to four parallel groups according to implant design (one-piece or two-piece bone-level) and peri-implant status (health or peri-implant mucositis). The two mucositis groups received the same nonsurgical therapy and were followed for 3 months, whereas the two healthy groups received no intervention and were assessed at baseline only.

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 23, 2026
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after publication of the main results and for 5 years thereafter.
• Access Criteria: Data will be shared with qualified researchers who submit a methodologically sound proposal to the principal investigator, upon reasonable request and with a data sharing agreement, subject to approval by the İnönü University Clinical Research Ethics Committee where required.

Locations

TU (1)