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

NCT04559802 | Completed

• 1 other identifier: 2020-341
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Soft tissue healing around dental implants

  4 months

Study Arms (2)

Transmucosal (Non-Submerged)

EXPERIMENTAL

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

Procedure: Transmucosal Technique

Submerged

ACTIVE COMPARATOR

Flaps will be advanced to achieve primary wound closure.

Procedure: Submerged Technique

Interventions

Transmucosal Technique PROCEDURE

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

Also known as: Non-submerged technique

Transmucosal (Non-Submerged)

Submerged Technique PROCEDURE

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

Submerged

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova South Eastern university

Davie, Florida, 33314, United States

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Stavros Sofos, DDS

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 23, 2020
• Study Start: October 2, 2020
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)