Overview

This trial is active, not recruiting.

Condition facial gingival profile
Treatments bone graft inside socket only, bone graft inside and outside socket, no bone graft
Sponsor Loma Linda University
Collaborator DentiumUSA
Start date March 2012
End date June 2017
Trial size 30 participants
Trial identifier NCT01547273, 5110339

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
bone graft inside socket only
bone graft inside socket only
bone graft inside socket only
(Experimental)
bone graft inside and outside socket
bone graft inside and outside socket
bone graft inside and outside socket
(Experimental)
no bone graft
no bone graft
no bone graft

Primary Outcomes

Measure
change in facial gingival profile
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients must be 18 years of age or older, are no longer growing and able to read and sign an informed consent. 2. Good oral hygiene. 3. A single failing maxillary anterior tooth (#6-11) with the presence of healthy adjacent teeth. 4. Adequate bone volume to accommodate an implant with minimum dimensions of 3.6 mm diameter and 10.0 mm length. 5. Presence of opposing dentition (natural teeth, fixed or removable prostheses) 6. Healthy soft tissue at the future implant site. Exclusion Criteria: 1. 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. 2. Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion 3. Smoker. 4. History of head and neck radiation. 5. Soft tissue defect (inflammation, tissue cleft, unhealthy tissue) around a future implant site. 6. Inability to achieve primary implant stability following immediate implant placement.

Additional Information

Official title 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
Principal investigator Joseph YK Kan, DDS, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Loma Linda University.