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

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

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

Study Overview

• Status: Completed
• Conditions: Tooth Loss
• Intervention / Treatment: Procedure: Transmucosal Technique; Procedure: Submerged Technique

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Kelley, DDS; Phone Number: 6197299579; Email: rk806@mynsu.nova.edu
• Study Contact Backup: Name: Theofilos Koutouzis, Master; Phone Number: 954-262-1742; Email: tkoutouzis@nova.edu

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33314
      • Nova South Eastern university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transmucosal (Non-Submerged); Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure	Procedure: Transmucosal Technique; Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).; Other Names: Non-submerged technique
Active Comparator: Submerged; Flaps will be advanced to achieve primary wound closure.	Procedure: Submerged Technique; Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Investigators: Principal Investigator: Stavros Sofos, DDS, Nova Southeastern University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 2020-341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No