Trial · NCT07892313
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Peri-Implant Sulcus Fluid Interleukin-1 Beta (IL-1β) Total Amount | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Peri-Implant Sulcus Fluid Interleukin-10 (IL-10) Total Amount | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Peri-Implant Sulcus Fluid Matrix Metalloproteinase-8 (MMP-8) Total Amount | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Peri-Implant Sulcus Fluid Tissue Inhibitor of Metalloproteinases-1 (TIMP-1) Total Amount | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Peri-Implant Sulcus Fluid IL-1β/IL-10 Ratio | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Peri-Implant Sulcus Fluid MMP-8/TIMP-1 Ratio | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Plaque Index | Baseline, 1 month, and 3 months after treatment | Plaque index recorded at six sites around the implant and averaged per implant (score 0 to 3, higher scores indicate more plaque). |
| Secondary | Change in Gingival Index | Baseline, 1 month, and 3 months after treatment | Gingival index recorded at six sites around the implant and averaged per implant (score 0 to 3, higher scores indicate more inflammation). |
| Secondary | Change in Probing Depth | Baseline, 1 month, and 3 months after treatment | Probing depth measured at six sites around the implant with a plastic periodontal probe and averaged per implant (mm). |
| Secondary | Change in Bleeding on Probing | Baseline, 1 month, and 3 months after treatment | Percentage of the six sites around the implant showing bleeding within approximately 10 s after gentle probing. |
| Secondary | Peri-Implant Soft-Tissue Phenotype | Baseline | 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. |
| Secondary | Peri-Implant Mucosal Thickness | Baseline | 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. |
| Secondary | Keratinized Mucosal Width | Baseline | Distance from the free mucosal margin to the mucogingival junction at the mid-buccal aspect of the implant (mm). |
| Secondary | Change in Relative Abundance of Porphyromonas gingivalis in Subgingival Plaque | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Relative Abundance of Fusobacterium nucleatum in Subgingival Plaque | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Relative Abundance of Treponema denticola in Subgingival Plaque | Baseline, 1 month, and 3 months after treatment | 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. |
| Secondary | Change in Relative Abundance of Filifactor alocis in Subgingival Plaque | Baseline, 1 month, and 3 months after treatment | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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