The Effect of Bone Grafts on Facial Gingival Profile in Maxillary Anterior Single Tooth Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Loma Linda University
Sponsor:
Collaborator:
Dentium USA
Information provided by (Responsible Party):
Joseph Kan, DDS, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01547273
First received: January 12, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Facial Gingival Profile
Procedure: bone graft inside socket only
Procedure: bone graft inside and outside socket
Procedure: no bone graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • change in facial gingival profile [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bone graft inside socket only
bone graft inside socket only
Procedure: bone graft inside socket only
bone graft inside socket only
Experimental: bone graft inside and outside socket
bone graft inside and outside socket
Procedure: bone graft inside and outside socket
bone graft inside and outside socket
Experimental: no bone graft
no bone graft
Procedure: no bone graft
no 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547273

Contacts
Contact: Joseph YK Kan, DDS, MS 909-558-8247 jkan@llu.edu
Contact: Pakpoom Yuenyongorarn, DDS, MS 951-801-1343 pyuenyongorarn@llu.edu

Locations
United States, California
Loma Linda University School of Dentistry Not yet recruiting
Loma Linda, California, United States, 92350
Contact: Joseph YK Kan, DDS, MS    909-558-8247    jkan@llu.edu   
Contact: Pakpoom Yuenyongorarn, DDS, MS    951-801-1343    pyuenyongorarn@llu.edu   
Implant Department, School of dentistry, Loma Linda University Recruiting
Loma Linda, California, United States, 92350
Contact: Joseph YK Kan, DDS,MS    909-558-4983    jkan@llu.edu   
Contact: Pakpoom Yuenyongorarn, DDS,MS    909-558-4983    pyuenyongorarn@llu.edu   
Principal Investigator: Joseph YK Kan, DDS,MS         
Sponsors and Collaborators
Loma Linda University
Dentium USA
Investigators
Principal Investigator: Joseph YK Kan, DDS, MS Loma Linda University School of Dentistry
  More Information

No publications provided

Responsible Party: Joseph Kan, DDS, Professor of Restorative dentistry, Loma Linda University
ClinicalTrials.gov Identifier: NCT01547273     History of Changes
Other Study ID Numbers: 5110339
Study First Received: January 12, 2012
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014