One-Piece Dental Implant1PvsBLNCT07892313
Inflammatory Biomarkers, Microbial Findings, and Clinical Characteristics Before and After Treatment of Peri-Implant Mucositis Around One-Piece and Two-Piece Dental Implants
A study testing Nonsurgical Mechanical Debridement With 1% Chlorhexidine Gel in people with One-Piece Dental Implant and Bone-Level Implant, run by Cuneyt Asim Aral at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- One-Piece Dental Implant, Bone-Level Implant, Two-Piece Dental Implant
- What is being tested?
- Nonsurgical Mechanical Debridement With 1% Chlorhexidine Gel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Antibiotic use within the previous 6 months
- Continuous systemic medication
- Implants in function for less than 6 months after prosthetic restoration
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Malatya, 44210
About this study
Official title: Effects of Periodontal Status and Initial Periodontal Therapy on Peri-Implant Sulcus Fluid Biomarkers in One-Piece and Two-Piece Implant Systems
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.
Read the detailed description
BACKGROUND Peri-implant mucositis is a plaque-associated inflammatory lesion of the soft tissues around dental implants and is considered the precursor of peri-implantitis. In two-piece bone-level implants, the implant-abutment interface and the internal cavity may act as reservoirs for bacterial penetration and retention, whereas one-piece implants have no such junction and a continuous transmucosal component. Whether this structural difference affects the host response to nonsurgical mucositis therapy had not been investigated together with clinical and microbiological changes. The primary aim of this study was to compare the changes in peri-implant sulcus fluid (PISF) levels of interleukin-1 beta (IL-1β), interleukin-10 (IL-10), matrix metalloproteinase-8 (MMP-8), and tissue inhibitor of metalloproteinases-1 (TIMP-1) over 3 months after nonsurgical therapy around one-piece and two-piece bone-level implants.
STUDY DESIGN The study was conducted at the Department of Periodontology, Faculty of Dentistry, İnönü University, Malatya, Türkiye, and consisted of two phases. In the cross-sectional phase, implants with peri-implant health and implants with peri-implant mucositis were compared for each implant design at baseline. In the prospective phase, implants with peri-implant mucositis received nonsurgical therapy and were re-examined and re-sampled 1 and 3 months after treatment. The one-piece implants were monoblock implants in which the endosseous and transmucosal portions are manufactured as a single unit (Monoimplant Rough B, Novodent SA, Switzerland), and the two-piece implants were bone-level implants from the same manufacturer (Implantswiss, Novodent SA, Switzerland). All implants had been placed by the same periodontist. Diagnoses were based on the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.
CLINICAL EXAMINATION All clinical measurements were performed by a single calibrated examiner. Plaque index, gingival index, probing depth, and bleeding on probing were recorded at six sites around each implant with a plastic periodontal probe. Keratinized mucosal width was measured at the mid-buccal aspect. Peri-implant soft-tissue phenotype was assessed with a color-coded probe, and mucosal thickness was measured by transgingival probing under topical anesthesia at 1, 2, and 3 mm apical to the buccal mucosal margin using an endodontic spreader and a caliper. Intra-examiner reliability was assessed by repeated measurements 10 days apart.
SAMPLING Samples were collected between 09:00 and 11:00 on the day after the clinical examination to avoid interference from probing-induced bleeding. After isolation and removal of supragingival deposits, subgingival plaque was collected with sterile paper points inserted at the mesial and distal aspects of each implant for 30 s. PISF was then collected with two paper strips inserted into the sulcus for 30 s each. Samples contaminated with blood or saliva were discarded, and all samples were stored at -80°C until analysis.
NONSURGICAL THERAPY Implants with peri-implant mucositis received mechanical debridement with an ultrasonic device fitted with polyetheretherketone-capped tips to avoid alteration of the implant surface. After isolation, 1% chlorhexidine gel was delivered into the peri-implant sulcus in a single session with a syringe and a 22-gauge needle. Participants were asked to avoid food and fluid intake for at least 2 hours and received individualized oral hygiene instructions, including the use of interdental brushes of appropriate size.
LABORATORY ANALYSES PISF IL-1β, IL-10, MMP-8, and TIMP-1 were quantified with sandwich enzyme-linked immunosorbent assay (ELISA) kits and expressed as total amounts per implant (two pooled strips, each collected for 30 s). The IL-1β/IL-10 and MMP-8/TIMP-1 ratios were calculated from the total amounts. Total DNA was extracted from the plaque samples, and Porphyromonas gingivalis, Fusobacterium nucleatum, Treponema denticola, and Filifactor alocis were analyzed by quantitative polymerase chain reaction (qPCR) with species-specific primers and universal 16S rRNA gene primers as the reference for total bacterial load. Relative abundance was expressed as ΔCt (Ct of the target species minus Ct of the 16S rRNA gene), and a species was considered not detected when no amplification occurred within 40 cycles.
SAMPLE SIZE The sample size was calculated with G*Power 3.1.9.7 from previously reported PISF IL-1β total amounts in healthy and inflamed implants (effect size d=0.87). With a two-sided alpha of 0.05 and 80% power, 22 implants per group (88 implants in total) were required.
STATISTICAL ANALYSIS Nonparametric methods were used. The four groups were compared at baseline with the Kruskal-Wallis test followed by Dunn's post hoc test with Bonferroni adjustment. Within-group changes over time were analyzed with the Friedman test followed by Bonferroni-adjusted Wilcoxon signed-rank tests. The two mucositis groups were compared at each time point and for reductions from baseline with the Mann-Whitney U test, with Hodges-Lehmann estimates and 95% confidence intervals for biomarker reductions. Categorical variables were compared with the chi-square test, and detection frequencies with Fisher's exact test between groups and Cochran's Q test followed by exact McNemar tests within groups. A two-sided p<0.05 was considered statistically significant.
- Conditions
- One-Piece Dental Implant, Bone-Level Implant, Two-Piece Dental Implant, Nonsurgical Mechanical Debridement, Chlorhexidine Gel, Soft Tissue Phenotype
- Being tested
- Nonsurgical Mechanical Debridement With 1% Chlorhexidine Gel
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical Mechanical Debridement With 1% Chlorhexidine GelProcedure or surgery
Also called Nonsurgical peri-implant mucositis therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, and 3 months after treatment
Secondary outcomes (16)
Change in Peri-Implant Sulcus Fluid Interleukin-10 (IL-10) Total Amount
Total amount of IL-10 in peri-implant sulcus fluid (pg per implant, two pooled paper strips each collected for 30 s), measured by ELISA.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Peri-Implant Sulcus Fluid Matrix Metalloproteinase-8 (MMP-8) Total Amount
Total amount of MMP-8 in peri-implant sulcus fluid (ng per implant, two pooled paper strips each collected for 30 s), measured by ELISA.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Peri-Implant Sulcus Fluid Tissue Inhibitor of Metalloproteinases-1 (TIMP-1) Total Amount
Total amount of TIMP-1 in peri-implant sulcus fluid (pg per implant, two pooled paper strips each collected for 30 s), measured by ELISA.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Peri-Implant Sulcus Fluid IL-1β/IL-10 Ratio
Ratio of the total amount of interleukin-1 beta (IL-1β) to the total amount of interleukin-10 (IL-10) in peri-implant sulcus fluid (pg/pg), calculated for each implant from enzyme-linked immunosorbent assay (ELISA) measurements.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Peri-Implant Sulcus Fluid MMP-8/TIMP-1 Ratio
Ratio of the total amount of matrix metalloproteinase-8 (MMP-8, ng) to the total amount of tissue inhibitor of metalloproteinases-1 (TIMP-1, pg) in peri-implant sulcus fluid (ng/pg), calculated for each implant from enzyme-linked immunosorbent assay (ELISA) measurements.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Plaque Index
Plaque index recorded at six sites around the implant and averaged per implant (score 0 to 3, higher scores indicate more plaque).
Measured: Baseline, 1 month, and 3 months after treatment
Change in Gingival Index
Gingival index recorded at six sites around the implant and averaged per implant (score 0 to 3, higher scores indicate more inflammation).
Measured: Baseline, 1 month, and 3 months after treatment
Change in Probing Depth
Probing depth measured at six sites around the implant with a plastic periodontal probe and averaged per implant (mm).
Measured: Baseline, 1 month, and 3 months after treatment
Change in Bleeding on Probing
Percentage of the six sites around the implant showing bleeding within approximately 10 s after gentle probing.
Measured: Baseline, 1 month, and 3 months after treatment
Peri-Implant Soft-Tissue Phenotype
Phenotype assessed with a color-coded probe and classified as thin, medium, thick, or very thick, compared between one-piece and two-piece bone-level implants.
Measured: Baseline
Peri-Implant Mucosal Thickness
Mucosal thickness measured by transgingival probing at 1, 2, and 3 mm apical to the buccal mucosal margin (mm), compared between one-piece and two-piece bone-level implants.
Measured: Baseline
Keratinized Mucosal Width
Distance from the free mucosal margin to the mucogingival junction at the mid-buccal aspect of the implant (mm).
Measured: Baseline
Change in Relative Abundance of Porphyromonas gingivalis in Subgingival Plaque
Relative abundance of Porphyromonas gingivalis in subgingival plaque determined by quantitative polymerase chain reaction (qPCR) and expressed as ΔCt (cycle threshold of Porphyromonas gingivalis minus cycle threshold of the 16S rRNA gene). Lower values indicate higher relative abundance. Non-detected samples (no amplification within 40 cycles) were assigned a Ct of 40.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Relative Abundance of Fusobacterium nucleatum in Subgingival Plaque
Relative abundance of Fusobacterium nucleatum in subgingival plaque determined by quantitative polymerase chain reaction (qPCR) and expressed as ΔCt (cycle threshold of Fusobacterium nucleatum minus cycle threshold of the 16S rRNA gene). Lower values indicate higher relative abundance. Non-detected samples (no amplification within 40 cycles) were assigned a Ct of 40.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Relative Abundance of Treponema denticola in Subgingival Plaque
Relative abundance of Treponema denticola in subgingival plaque determined by quantitative polymerase chain reaction (qPCR) and expressed as ΔCt (cycle threshold of Treponema denticola minus cycle threshold of the 16S rRNA gene). Lower values indicate higher relative abundance. Non-detected samples (no amplification within 40 cycles) were assigned a Ct of 40.
Measured: Baseline, 1 month, and 3 months after treatment
Change in Relative Abundance of Filifactor alocis in Subgingival Plaque
Relative abundance of Filifactor alocis in subgingival plaque determined by quantitative polymerase chain reaction (qPCR) and expressed as ΔCt (cycle threshold of Filifactor alocis minus cycle threshold of the 16S rRNA gene). Lower values indicate higher relative abundance. Non-detected samples (no amplification within 40 cycles) were assigned a Ct of 40.
Measured: Baseline, 1 month, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for One-Piece Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cuneyt Asim Aral
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Harvard School of Dental Medicine, University of Minnesota
- Responsible party
- Sponsor-investigator, Cuneyt Asim Aral, Inonu University
- Investigators
- Cüneyt A Aral, Chair, Professor, DDS, PhD, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892313
- Sponsor's protocol ID
- IUCREC.2024.181
- Acronym
- 1PvsBL
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication, including clinical periodontal and peri-implant parameters, peri-implant sulcus fluid biomarker levels, and quantitative PCR results, will be shared.
Publications
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.
PubMed 38980075Sun 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.
PubMed 36726642Cota 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.
PubMed 42309165Jervoe-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.
PubMed 24861845Renvert 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.
PubMed 25867993Isola 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.
PubMed 39865359Goncalves 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.
PubMed 39860346Severino 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.
PubMed 27608364Arakawa 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.
PubMed 23083963Kao 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.
PubMed 8530172