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Completed

NCT Number: NCT04559802

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.

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova South Eastern university

Davie, Florida, 33314, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transmucosal Technique

Procedure

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

Other names: Non-submerged technique

Submerged Technique

Procedure

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

Primary outcomes

  1. Hard tissue healing around dental implants

    Time frame: 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 outcomes

  1. Soft tissue healing around dental implants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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