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Clinical Trials/NCT01547273
NCT01547273
Completed
Not Applicable

The Effect of Bone and Connective Tissue Grafts on Facial Gingival Profile in Single Maxillary Anterior Immediate Implant Placement and Provisionalization: A 1-Year Prospective Study

Loma Linda University2 sites in 1 country30 target enrollmentMarch 20, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Facial Gingival Profile
Sponsor
Loma Linda University
Enrollment
30
Locations
2
Primary Endpoint
change in facial gingival profile
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this investigator-initiated study is to evaluate the facial gingival profile following immediate implant placement and provisionalization in conjunction with connective tissue graft with or without bone graft

Detailed Description

Thirty subjects who are at least 18 years old with a failing upper front tooth seeking for implant treatment will be recruited at Loma Linda University School of Dentistry (LLUSD), where the consent will also take place. The subjects will be randomly divided into 3 groups. The subjects will receive immediate implant placement and provisionalization (IIPP) in conjunction with connective tissue graft (CTG) with (Group I) or without (Group II) bone graft in the extraction socket; and with bone graft in extraction socket and at the facial aspect of failing tooth (Group III). Clinical, radiographic and model assessments will be performed at different time intervals (pre-treatment to 12 months after implant placement) and statistically analyzed (α = 0.05) to evaluate peri-implant tissue response and facial gingival profile of the implants. Complications, if any, will also be recorded and appropriately addressed.

Registry
clinicaltrials.gov
Start Date
March 20, 2012
End Date
April 7, 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients must be 18 years of age or older, are no longer growing and able to read and sign an informed consent.
  • Good oral hygiene.
  • A single failing maxillary anterior tooth (#6-11) with the presence of healthy adjacent teeth.
  • Adequate bone volume to accommodate an implant with minimum dimensions of 3.6 mm diameter and 10.0 mm length.
  • Presence of opposing dentition (natural teeth, fixed or removable prostheses)
  • Healthy soft tissue at the future implant site.

Exclusion Criteria

  • A medical history that would complicate the outcome of study such as alcohol or drug dependency, poor health ,uncontrolled diabetes, immunodeficiency diseases, taking any medication that may cause gingival over growth or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and required follow-up examinations.
  • Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion
  • History of head and neck radiation.
  • Soft tissue defect (inflammation, tissue cleft, unhealthy tissue) around a future implant site.
  • Inability to achieve primary implant stability following immediate implant placement.

Outcomes

Primary Outcomes

change in facial gingival profile

Time Frame: 1 year

Study Sites (2)

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