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

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

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

Study Overview

• Status: Completed
• Conditions: Facial Gingival Profile
• Intervention / Treatment: Procedure: bone graft inside socket only; Procedure: bone graft inside and outside socket; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University School of Dentistry
    • Loma Linda, California, United States, 92350
      • Implant Department, School of dentistry, Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bone graft inside socket only	Procedure: bone graft inside socket only; bone graft inside socket only
Experimental: bone graft inside and outside socket	Procedure: bone graft inside and outside socket; bone graft inside and outside socket
Experimental: no bone graft	Procedure: no bone graft; no bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in facial gingival profile	1 year

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: DentiumUSA
• Investigators: Principal Investigator: Joseph YK Kan, DDS, MS, Loma Linda University School of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2012
• Primary Completion (Actual): April 7, 2016
• Study Completion (Actual): April 7, 2016

Study Registration Dates

• First Submitted: January 12, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: 5110339

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No