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

NCT ID: NCT04559802

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2024-02-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Tooth Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transmucosal (Non-Submerged)

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

Group Type EXPERIMENTAL

Transmucosal Technique

Intervention Type PROCEDURE

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

Submerged

Flaps will be advanced to achieve primary wound closure.

Group Type ACTIVE_COMPARATOR

Submerged Technique

Intervention Type PROCEDURE

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

Interventions

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Transmucosal Technique

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

Intervention Type PROCEDURE

Submerged Technique

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

Intervention Type PROCEDURE

Other Intervention Names

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Non-submerged technique

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Theofilos Koutouzis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stavros Sofos, DDS

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

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Nova South Eastern university

Davie, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2020-341

Identifier Type: -

Identifier Source: org_study_id

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