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Completed

NCT Number: NCT07584759

Evaluation of Fluid Biomarkers Around Implants Exhibiting Early Stage Periimplant Bone Loss

This study aimed to compare biological mediators known to be important in peri-implant diseases in implants with and without early stage marginal bone loss. A total of 118 implants in 59 patients were designated as test and control groups. The radiographic and periodontal data of the included implants, along with peri-implant sulcus fluid samples, were evaluated.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University, Faculty of Dentistry, Periodontology

Denizli, 20160, Turkey (Türkiye)

About this study

This study included clinical and radiographic records of patients who received implant treatment in the maxilla and/or mandible between 11/2021 and 9/2024. Patients were divided into test and control groups based on the presence/absence of EMBL after prosthetic loading. Periodontal clinical measurements were recorded and peri-implant sulcus fluid (PISF) samples were collected. Sclerostin, calprotectin, type I collagen cross-linked N-telopeptide (NTx), matrix metalloproteinase (MMP)-8, and MMP-9 levels were analyzed using ELISA. Group comparisons were performed with the statistical analyses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of 1 mm or more of radiographic marginal bone loss within the first 3 months after implant placement
  • Availability of radiographic documentation
  • Availability of demographic data, surgical records, and data related to the implant used
  • Physical condition classified as Class I and II according to the American Society of Anesthesiologists (ASA) classification
  • Patients with no smoking history in the last 10 years
  • Fixed implant-supported restorations
  • Screw-retained implants

Exclusion criteria

  • Patients receiving and/or maintaining implant treatment at centers other than the Department of Periodontology, Pamukkale University Faculty of Dentistry
  • Patients with incomplete or unreachable files or radiographic documentation
  • Patients with a known systemic disease/condition that alters their physical condition or bone metabolism
  • Severe bruxism cases
  • Pregnant and breastfeeding patients
  • Patients with incomplete implant-supported prosthesis
  • Areas grafted during or before implant surgery
  • Removable implant-supported restorations
  • Cement-retained implants
  • Patients undergoing peri-implantitis treatment

Treatment and study plan

Collecting of peri-implant sulcus fluid

Other

To evaluate biomarkers associated with peri-implant bone loss, periopaper was placed in the peri-implant pocket and absorbed with sulcus fluid.

Periapical radiography

Diagnostic Test

Parallel cone technique was used during periapical imaging to accurately measure peri-implant bone loss.

Primary outcomes

  1. Calprotectin levels in peri-implant crevicular fluid

    Time frame: 6-8 week after prosthetic treatment

    After collecting peri-implant sulcus fluid using the paper strip method, calprotectin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.

  2. Sclerostin levels in peri-implant crevicular fluid

    Time frame: 6-8 week after prosthetic treatment

    After collecting peri-implant sulcus fluid using the paper strip method, sclerostin levels in the peri-implant sulcus region were determined using the ELISA method and recorded in pg/ml.

  3. NTx levels in peri-implant crevicular fluid

    Time frame: 6-8 week after prosthetic treatment

    After collecting peri-implant sulcus fluid using the paper strip method, NTx levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.

  4. MMP-8 levels in peri-implant crevicular fluid

    Time frame: 6-8 week after prosthetic treatment

    After collecting peri-implant sulcus fluid using the paper strip method, MMP-8 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.

  5. MMP-9 levels in peri-implant crevicular fluid

    Time frame: 6-8 week after prosthetic treatment

    After collecting peri-implant sulcus fluid using the paper strip method, MMP-9 levels in the peri-implant sulcus region were determined using the ELISA method and recorded in ng/ml.

Other outcomes

  1. Radiographic detecting of Peri-implant marginal bone loss

    Time frame: Baseline, 3 months

    The amount of marginal bone loss was determined by comparing the periapical radiograph taken on the day the implants were placed with the radiograph taken at 3 months. Measurements of digital radiographic images were performed using computer software. Then, study groups were determined according to the presence or absence of peri-implant marginal bone loss.

  2. Modified Bleeding İndex

    Time frame: During the same session as the peri-implant fluid collection procedure

    This assessment was performed based on the bleeding response following gentle probing with a plastic probe in the four regions of each implant (mesial, distal, palatal/lingual, and buccal). The severity of bleeding observed within approximately 10-30 seconds after probing was scored and recorded. The scoring system was graded as follows: 0: no bleeding, 1: bleeding at a single point, 2: bleeding at several points or in a linear pattern, 3: heavy bleeding following probing.

  3. Peri-implant pocket depth

    Time frame: During the same session as the peri-implant fluid collection procedure

    A plastic periodontal probe was used to determine peri-implant pocket depth. Measurements were taken by using the probe, supported by its own weight, parallel to the long axis of the tooth. Pocket depth was measured at 6 sites (mesio-buccal, buccal, disto-buccal, mesio-palatal/lingual, palatal/lingual, disto-palatal/lingual) for each implant included in the study and recorded in millimeters (mm). The pocket depth value for each dental implant was obtained by calculating the average of the 6 measured values.

  4. Gingival İndex

    Time frame: During the same session as the peri-implant fluid collection procedure

    The mesial, distal, buccal, and lingual/palatal surfaces of each tooth/implant were evaluated separately, and the average of the scores obtained was recorded as the gingival index value for that tooth/implant. Scoring during the evaluation was performed as follows: 0 = normal gingiva, 1 = mild inflammation (color change, mild edema, no bleeding on probing), 2 = moderate inflammation (redness, edema, bleeding on probing), 3 = severe inflammation (marked redness, edema, ulceration, spontaneous bleeding). Subsequently, all values were summed and divided by the total number of teeth and implants to record the gingival index score.

  5. Modified Plaque İndex

    Time frame: During the same session as the peri-implant fluid collection procedure

    The mesial, distal, buccal, and lingual/palatal surfaces around the teeth/implants were examined, and the average of the scores obtained for each surface was recorded as the plaque index for that tooth/implant. The scoring criteria were as follows: 0 = no plaque, 1 = plaque detectable only with a probe, 2 = soft plaque accumulation visible to the naked eye, 3 = the tooth surface covered with a distinct plaque layer. Subsequently, all values were summed and divided by the total number of teeth and implants to record the modified plaque index score.

  6. Peri-implant mucosal recession

    Time frame: During the same session as the peri-implant fluid collection procedure

    The abutment-implant interface was designated as the reference point for determining the extent of peri-implant mucosal recession, and the distance between the reference point and the free gingival margin was measured using a periodontal probe. Mucosal recession was recorded in four regions (mesio-buccal, mid-buccal, disto-buccal, mid-lingual/palatal) for each implant included in the study. The recession value for each implant was obtained by calculating the average of the four measured values.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Collaborators

  • Pamukkale University scientific research project department

Registry information

Official study title

Evaluation of Biomarkers Involved In Bone Metabolism (Remodeling) In Periimplanter Crevicular Fluid of Implants With Early Marginal Bone Loss: A Retrospective Clinical Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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