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Completed

NCT Number: NCT01547273

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be 18 years of age or older, are no longer growing and able to read and sign an informed consent.
  • Good oral hygiene.
  • A single failing maxillary anterior tooth (#6-11) with the presence of healthy adjacent teeth.
  • Adequate bone volume to accommodate an implant with minimum dimensions of 3.6 mm diameter and 10.0 mm length.
  • Presence of opposing dentition (natural teeth, fixed or removable prostheses)
  • Healthy soft tissue at the future implant site.

Exclusion criteria

  • 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.
  • Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion
  • Smoker.
  • History of head and neck radiation.
  • Soft tissue defect (inflammation, tissue cleft, unhealthy tissue) around a future implant site.
  • Inability to achieve primary implant stability following immediate implant placement.

Treatment and study plan

bone graft inside socket only

Procedure

bone graft inside socket only

bone graft inside and outside socket

Procedure

bone graft inside and outside socket

no bone graft

Procedure

no bone graft

Primary outcomes

  1. change in facial gingival profile

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • DentiumUSA

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 7, 2012
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.