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| ID | Type | Description | Link |
|---|---|---|---|
| 2025DİŞF001 | Other Identifier | Office of Scientific Research Projects of Pamukkale University |
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| Name | Class |
|---|---|
| Pamukkale University scientific research project department | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Presence of marginal bone loss of 1 mm or more within the first 3 months after implant placement |
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| Control | Presence of less than 1 mm of marginal bone loss within the first 3 months after implant placement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Calprotectin levels in peri-implant crevicular fluid | 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. | 6-8 week after prosthetic treatment |
| Sclerostin levels in peri-implant crevicular fluid | 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. | 6-8 week after prosthetic treatment |
| NTx levels in peri-implant crevicular fluid | 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. | 6-8 week after prosthetic treatment |
| MMP-8 levels in peri-implant crevicular fluid | 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. | 6-8 week after prosthetic treatment |
| MMP-9 levels in peri-implant crevicular fluid | 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. | 6-8 week after prosthetic treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic detecting of Peri-implant marginal bone loss | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Patients who received implant treatment at the Department of Periodontology, Pamukkale University Faculty of Dentistry.
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| Name | Affiliation | Role |
|---|---|---|
| Raziye Tugce Can Keles, R.A. | Pamukkale University Faculty of Dentistry, Department of Periodontology | Principal Investigator |
| Gizem Torumtay Cin, Assoc. Prof. | Pamukkale University Faculty of Dentistry, Department of Periodontology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamukkale University, Faculty of Dentistry, Periodontology | Denizli | 20160 | Turkey (Türkiye) |
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peri-implant crevicular fluid
| Periapical radiography | Diagnostic Test | Parallel cone technique was used during periapical imaging to accurately measure peri-implant bone loss. |
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| Baseline, 3 months |
| Modified Bleeding İndex | 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. | During the same session as the peri-implant fluid collection procedure |
| Peri-implant pocket depth | 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. | During the same session as the peri-implant fluid collection procedure |
| Gingival İndex | 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. | During the same session as the peri-implant fluid collection procedure |
| Modified Plaque İndex | 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. | During the same session as the peri-implant fluid collection procedure |
| Peri-implant mucosal recession | 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. | During the same session as the peri-implant fluid collection procedure |
| ID | Term |
|---|---|
| C537525 | Sclerosteosis |
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