Clinical trial NCT01547273: The Effect of Bone Grafts on Facial Gingival Profile in Maxillary Anterior Single Tooth Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Gingival Profile
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: DentiumUSA
First posted: 2012-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: change in facial gingival profile
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Implant Department, School of dentistry, Loma Linda University
state: California
city: Loma Linda
country: United States
facility: Loma Linda University School of Dentistry
state: California
Study officials:
affiliation: Loma Linda University School of Dentistry
name: Joseph YK Kan, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: