Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation

Tooth Loss Clinical Trial

Official title:

Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559802
• Other study ID #: 2020-341
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Tooth Loss

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