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

Not Applicable

Completed

• Conditions: Tooth Loss
• Interventions: Procedure: Transmucosal Technique; Procedure: Submerged Technique

• Registration Number: NCT04559802
• Lead Sponsor: Nova Southeastern University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Study Start: 2020-10-02
• Status Verified: 2024-02
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transmucosal (Non-Submerged)	Transmucosal Technique	Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure
Submerged	Submerged Technique	Flaps will be advanced to achieve primary wound closure.

Primary Outcome Measures

Name	Time	Method
Hard tissue healing around dental implants	4 months	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

Name	Time	Method
Soft tissue healing around dental implants	4 months	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.

Trial Locations

Locations (1)

Nova South Eastern university; 🇺🇸 Davie, Florida, United States