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

Facial Gingival Profile Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547273
• Other study ID #: 5110339
• Status: Completed
• Phase: N/A
• Start date: March 20, 2012
• Est. completion date: April 7, 2016

Study information

• Verified date: April 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 7, 2016
• Est. primary completion date: April 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Gingival Profile
• Facies

Intervention

Procedure:
• bone graft inside socket only
bone graft inside socket only
• bone graft inside and outside socket
bone graft inside and outside socket
• no bone graft
no bone graft

Locations

Country	Name	City	State
United States	Implant Department, School of dentistry, Loma Linda University	Loma Linda	California
United States	Loma Linda University School of Dentistry	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	DentiumUSA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in facial gingival profile		1 year