Dimensional Soft and Hard Tissue Alterations Following Single Tooth Extraction in the Anterior Maxilla - A Prospective Clinical Study (Alterations)

March 25, 2015 updated by: University of Bern

Ridge Alterations Following Single Tooth Extraction in the Anterior Maxilla - A Prospective Clinical Study

Bone modeling after tooth extraction has a major consequence on implant therapy, in particular in the esthetic zone. In esthetic sites, no tissue loss should occur if an optimal esthetic outcome is expected. Recent experimental studies in dogs have shown that neither an immediate implant insertion nor ridge preservation techniques can prevent this bone modeling process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background

The alveolar process is a tooth dependent tissue and develops in conjunction with the eruption of teeth. The size and the form of the tooth, the axis of eruption and eventual inclination determine the local volume as well as the shape of the alveolar process. It has been shown that after removing all teeth in humans, the alveolar ridge undergoes a process of resorption and atrophy.

In a recent animal study, Cardaropoli et al. (2003) assessed the healing events occurring in the extraction socket following tooth removal. The findings of this study demonstrated that the healing of an extraction socket involved a series of events including the formation of a coagulum that was replaced by a provisional connective tissue matrix, woven bone and lamellar bone and bone marrow. On day 30, mineralized bone occupied 88% of the socket volume. Hard tissue formation had started already after 2 weeks of healing, and then, after a month, the socket was filled with woven bone. Later, the woven bone was gradually replaced by lamellar bone and bone marrow. After 3 months of healing, a hard tissue bridge was consistently found to cover the crestal portion of the extraction site, which was formed by woven bone and lamellar bone. Araújo et al. (2005) analysed in an experimental study in dogs the ridge alterations following the extraction of premolars in the mandible. The authors observed that the resorption of the buccal and lingual walls occurred in two overlapping phases. Phase 1: The bundle bone - that lost its function and blood supply - was resorbed and replaced with woven bone. Vertical resorption was considerably greater on the buccal aspect of the alveolar crest, since this bone wall was much thinner then the lingual wall and was primarily comprised of bundle bone. Phase 2: An additional resorption occurred from the outer surfaces of both bone walls. The reason for this additional resorption has not been clearly ascertained. The hypothesis could be: Impaired superficial vascularisation by raising a mucoperiosteal flap; adjusting to the lack of continuous function; or the reestablishment of the ridge shape, which is genetically determined in the absence of teeth. A recent animal study confirmed that flap elevation plays an important role for a more pronounced superficial bone resorption following extraction , therefore, it seems critical that tooth extraction should be carried out without elevation of a mucoperiosteal flap. Even ridge preservation techniques are not able to prevent the contour changes after tooth extraction.

Objective

The aim of the present clinical study is to examine the dimensional changes of the alveolar ridge following single tooth extraction in the anterior maxilla of patients, in particular on the facial aspect of the alveolar ridge. These horizontal and vertical changes will be sequentially documented up to 8 weeks of healing before an implant is inserted using the concept of early implant placement. The study will also provide information about the anatomic situation of the facial bone wall in the anterior maxilla at the time of extraction, and the prevalence and extent of bone deficiencies on the facial aspect, when teeth need to be extracted.

Methods

To document these changes over time, two methods will be applied. Firstly, two cone beam computed tomographies (CBCT) will be obtained, one directly after tooth extraction, the other one at 8 weeks of socket healing prior to implant placement. The two CBCT's will be analyzed with a novel software program (InVivo Dental). Secondly, consecutive impressions will be made at day 0 (day of extraction), day 14, 28, 42, and 56 to digitally produce virtual 3D study models. These models can be analyzed with another software program (Geomagic) to document the variations of the soft tissue in the extraction site.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Bern
      • University of Bern, Bern, Switzerland, 3010
        • Dep. of Oral Sugery and Stomatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The group is selected from the referred patient pool. Age 18 or older. Absence of significant medical conditions. Sites with a need for single tooth extraction in the anterior maxilla.

Description

Inclusion Criteria:

  • Signed informed consent
  • Age 18 years or older
  • Absence of significant medical conditions
  • Patients with healthy or effectually treated periodontal conditions
  • Candidate for single tooth replacement in the anterior maxilla

Exclusion Criteria

  • General contraindications for dental and/or surgical treatments
  • Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
  • Inflammatory and autoimmune disease of oral cavity
  • Uncontrolled diabetes
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All study participants
One group observation study
Device: Cone beam computed tomography (CBCT)
Dimensional changes are documented over a healing period of 8-weeks following single tooth extraction. To document these changes over time, two methods will be applied. Firstly, two cone beam computed tomographies (CBCT) will be obtained, one directly after tooth extraction, the other one at 8 weeks of socket healing prior to implant placement. The two CBCT's will be analyzed with a novel software program (InVivo Dental). Secondly, consecutive impressions will be made at day 0 (day of extraction), day 14, 28, 42, and 56 to digitally produce virtual 3D study models. These models can be analyzed with another software program (Geomagic Studi 10) to document the variations of the soft tissue in the extraction site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in bone loss
Time Frame: 2-, 4-, 6-, 8-weeks
Measured by segmented surface model superimpositions. Changes in bone loss between baseline and 8 week healing period using CBCT technology. From the Digital Imaging and Communications in Medicine (DICOM) files two surface mesh model were generated, which were superimposed and the changes were subsequently analyzed.
2-, 4-, 6-, 8-weeks
Change from baseline in soft tissue loss
Time Frame: 2-, 4-, 6-, 8-weeks
Changes in soft tissue loss at baseline, 2-, 4-, 6- and 8 weeks were analyzed be dental impressions, which were superimposed as well and the changes were analyzed.
2-, 4-, 6-, 8-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing.
Time Frame: At baseline and 8-weeks
To measure correlation, the Spearman Rank Correlation Coefficient was calculated. Nonparametric models for longitudinal data were applied to analyze the impact of bone wall phenotype and healing period upon dimensional alterations.
At baseline and 8-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Collaborators

ITI Foundation

Investigators

  • Principal Investigator: Chappuis, Dep. Oral surgery and Stomatology, University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 079/09
  • Grant No. 624_2009 (Other Identifier: ITI Foundation, Basel, Switzerland)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dimensional Alterations

Clinical Trials on Cone beam computed tomography (CBCT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe