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The aim of a study was to analyze the effect of implant placement depth (4 mm versus 6 mm below the mid-facial gingival margin) on marginal bone loss (MBL) around implant and implant stability during immediate implant placement after tooth extraction. Clinical trial was conducted involving 35 patients requiring immediate implant placement after tooth extraction. Implants were placed either 4 mm (control group) or 6 mm (test group) below the mid-facial gingival margin. Primary outcome was deemed to be radiographic assessment of marginal bone level from periapical radiographs. Secondary outcome was implant stability quotient registration using resonance freaquency analyzer. The null hypothesis is that there is no significant difference in peri-implant marginal bone loss between implants placed at 4 mm depth versus 6 mm depth relative to the buccal gingival margin during immediate implant placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mm | Active Comparator |
| |
| 6 mm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implants were positioned 4 mm below the mid-facial gingival margin | Procedure | Tooth was carefully extracted and implant was placed 4 mm below free gingival margin of the extracted tooth. |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal bone loss around dental implant | From implant restoration delivery till 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability quotient | After implant placement and after 4 months |
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Inclusion Criteria:
1) age ≥ 18 years; (2) generally healthy individuals with no medical contraindications for implant surgery; (3) healthy soft tissue, indicated by bleeding on probing (BOP) < 20% and Plaque Index (PI) < 25%; (4) keratinized gingiva ≥ 2 mm, both buccally and lingually; (5) presence of molar or premolar in the upper or lower jaw; (6) implant primary stability ≥ 35 Ncm; (7) intact alveolar bone walls post-extraction; (8) one study implant per patient; and (9) signed informed consent with permission to utilize data for research purposes
Exclusion Criteria:
(1) smoking (≥ 10 cigarettes/day); (2) history of uncontrolled periodontitis; (3) uncontrolled diabetes or alcoholism; (4) medications known to impair healing; and (5) implant primary stability < 35 Ncm
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Kaunas | Lithuania |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2020 |
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| Implant was placed 6 mm below free gingival margin | Procedure | Tooth was extracted and dental implant placed 6 mm below free gingival margin of the extracted tooth. |
|
| May 1, 2026 |
| Prot_SAP_000.pdf |