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

Nova Southeastern University (NSU) logo

Nova Southeastern University (NSU)

Status

Completed

Conditions

Tooth Loss

Treatments

Procedure: Submerged Technique
Procedure: Transmucosal Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT04559802
2020-341

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Transmucosal (Non-Submerged)
Experimental group
Description:
Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure
Treatment:
Procedure: Transmucosal Technique
Submerged
Active Comparator group
Description:
Flaps will be advanced to achieve primary wound closure.
Treatment:
Procedure: Submerged Technique

Trial contacts and locations

1

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Central trial contact

Theofilos Koutouzis, Master; Robert Kelley, DDS

Data sourced from clinicaltrials.gov

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