Effects of Implant Placement Depth (4 mm Versus 6 mm) on Crestal Bone Stability in Immediate Implant Placement: A Clinical Study With 1-Year Post-Restorative Results
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Marginal bone loss around dental implant
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
4 mm
Intervention: Implants were positioned 4 mm below the mid-facial gingival margin (Procedure)
6 mm
Intervention: Implant was placed 6 mm below free gingival margin (Procedure)
Outcomes
Primary Outcomes
Marginal bone loss around dental implant
Time Frame: From implant restoration delivery till 1 year follow-up
Secondary Outcomes
- Implant stability quotient(After implant placement and after 4 months)
Investigators
Tomas Linkevicius
Professor
Lithuanian University of Health Sciences