- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07574710
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaunas, Lithuania
- Lithuanian University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 4 mm
|
Tooth was carefully extracted and implant was placed 4 mm below free gingival margin of the extracted tooth.
|
|
Experimental: 6 mm
|
Tooth was extracted and dental implant placed 6 mm below free gingival margin of the extracted tooth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Marginal bone loss around dental implant
Time Frame: From implant restoration delivery till 1 year follow-up
|
From implant restoration delivery till 1 year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Implant stability quotient
Time Frame: After implant placement and after 4 months
|
After implant placement and after 4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BEC-LSMU(R)-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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