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

Primary Purpose

Tooth Loss

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transmucosal Technique

Submerged Technique

About this trial

This is an interventional treatment trial for Tooth Loss

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Nova South Eastern university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transmucosal (Non-Submerged)

Submerged

Arm Description

Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure

Flaps will be advanced to achieve primary wound closure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04559802

First Posted

September 6, 2020

Last Updated

August 18, 2023

Sponsor

Nova Southeastern University

1. Study Identification

Unique Protocol Identification Number

NCT04559802

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2, 2020 (Actual)

Primary Completion Date

February 15, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nova Southeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tooth Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transmucosal (Non-Submerged)

Arm Type

Experimental

Arm Description

Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure

Arm Title

Submerged

Arm Type

Active Comparator

Arm Description

Flaps will be advanced to achieve primary wound closure.

Intervention Type

Procedure

Intervention Name(s)

Transmucosal Technique

Other Intervention Name(s)

Non-submerged technique

Intervention Description

Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).

Intervention Type

Procedure

Intervention Name(s)

Submerged Technique

Intervention Description

Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).

Primary Outcome Measure Information:

Title

Hard tissue healing around dental implants

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Soft tissue healing around dental implants

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stavros Sofos, DDS

Organizational Affiliation

Nova Southeastern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nova South Eastern university

City

Davie

State/Province

Florida

ZIP/Postal Code

33314

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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