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Clinical Trials/NCT03319758
NCT03319758
Active, not recruiting
Not Applicable

Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla

Sun Yat-sen University1 site in 1 country15 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Jaw, Edentulous, Partially
Sponsor
Sun Yat-sen University
Enrollment
15
Locations
1
Primary Endpoint
Radiographic bone volume
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.

Detailed Description

The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a final impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
November 2027
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Baoxin Huang

Principal Investigator

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Radiographic bone volume

Time Frame: Up to 10 years after baseline

Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

Secondary Outcomes

  • Visual analogue scale (VAS)(Up to 10 years after baseline)
  • Papilla volume(Up to 10 years after baseline)
  • Change of Pink and white esthetic scores (PES/WES)(Change from baseline up to 10 years after implantation)
  • Buccal marginal recession(Up to 10 years after baseline)
  • Oral health impact profile shortened version (OHIP-I)(Up to 10 years after baseline)
  • Width of keratinized gingiva(Up to 10 years after baseline)
  • Probing depth(Up to 10 years after baseline)
  • Modified plaque index(Up to 10 years after baseline)
  • Implant survival(Up to 10 years after baseline)
  • Modified bleeding index(Up to 10 years after baseline)

Study Sites (1)

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