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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04559802
Other study ID # 2020-341
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2020
Est. completion date February 15, 2024

Study information

Verified date February 2024
Source Nova Southeastern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.


Description:

Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date February 15, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Age more than 21 years - ASA I or II. - Patient's willingness to participate in this study. - Availability for 4-month follow-up. - Absence of active periodontal disease. - Single tooth replacement is needed with simultaneous contour augmentation. - Available pre-operative CBCT study. - Extraction of tooth at least 8 weeks prior to planned implant therapy. Exclusion Criteria: - Pregnancy at the screening visit. - Smoking more than 10 cig/day. - Active infection at the site of surgery (teeth involved). - Multiple missing teeth adjacent to each other (long span edentulous area). - Vertical bone defect less than 2mm (intra surgical assessment)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transmucosal Technique
Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).
Submerged Technique
Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).

Locations

Country Name City State
United States Nova South Eastern university Davie Florida

Sponsors (1)

Lead Sponsor Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hard tissue healing around dental implants bone healing around Submerged and Non-submerged dental implants will be measured by Periodontal probe and radiographs. A Mann-Whitney U Test will be used to calculate bone healing changes. To evaluate bone healing Mean values, standard deviations and frequencies will be calculated. 4 months
Secondary Soft tissue healing around dental implants Soft tissue healing around Submerged and Non-submerged dental implants. Fisher's exact test will be used to evaluate soft tissue healing changes through analyzing the measurements obtained by periodontal probe and radiographs. 4 months
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