Dimensional AlterationsAlterationsNCT02403700
Dimensional Soft and Hard Tissue Alterations Following Single Tooth Extraction in the Anterior Maxilla - A Prospective Clinical Study
An observational study of Dimensional Alterations, run by University of Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dimensional Alterations
- What is being tested?
- Cone beam computed tomography (CBCT)
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Oral Sugery and Stomatology
University of Bern, Canton of Bern, 3010
About this study
Official title: 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.
Read the 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.
- Conditions
- Dimensional Alterations
- Being tested
- Cone beam computed tomography (CBCT)
- Keywords
- bone remodeling, bone resorption, three-dimensional imaging, clinical trial, dental implant, maxilla, bone healing
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone beam computed tomography (CBCT)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | One group observation study Receives: Device: Cone beam computed tomography (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in bone loss
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.
Measured: 2-, 4-, 6-, 8-weeks
Change from baseline in soft tissue loss
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.
Measured: 2-, 4-, 6-, 8-weeks
Secondary outcomes (1)
Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing.
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.
Measured: At baseline and 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startOct 2009
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dimensional AlterationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- ITI Foundation
- Responsible party
- Sponsor
- Investigators
- Chappuis, Principal investigator, Dep. Oral surgery and Stomatology, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403700
- Sponsor's protocol ID
- 079/09
- Other IDs
- Grant No. 624_2009
- Acronym
- Alterations
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.
PubMed 12956657Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x.
PubMed 17092218Araujo MG, Lindhe J. Ridge alterations following tooth extraction with and without flap elevation: an experimental study in the dog. Clin Oral Implants Res. 2009 Jun;20(6):545-9. doi: 10.1111/j.1600-0501.2008.01703.x.
PubMed 19515033Januario AL, Duarte WR, Barriviera M, Mesti JC, Araujo MG, Lindhe J. Dimension of the facial bone wall in the anterior maxilla: a cone-beam computed tomography study. Clin Oral Implants Res. 2011 Oct;22(10):1168-1171. doi: 10.1111/j.1600-0501.2010.02086.x. Epub 2011 Feb 15.
PubMed 21320168Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler M. Tissue alterations after tooth extraction with and without surgical trauma: a volumetric study in the beagle dog. J Clin Periodontol. 2008 Apr;35(4):356-63. doi: 10.1111/j.1600-051X.2008.01209.x.
PubMed 18353082Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler MB. Hard tissue alterations after socket preservation: an experimental study in the beagle dog. Clin Oral Implants Res. 2008 Nov;19(11):1111-8. doi: 10.1111/j.1600-0501.2008.01575.x.
PubMed 18983313Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PubMed 12956475Chappuis V, Engel O, Shahim K, Reyes M, Katsaros C, Buser D. Soft Tissue Alterations in Esthetic Postextraction Sites: A 3-Dimensional Analysis. J Dent Res. 2015 Sep;94(9 Suppl):187S-93S. doi: 10.1177/0022034515592869. Epub 2015 Jun 30.
PubMed 26130259
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Alterations Following Single Tooth Extraction in the Anterior Maxilla - A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02403700
- Acronym / sponsor ID
- Alterations / 079/09
- Conditions
- Dimensional Alterations
- Keywords
- bone remodeling, bone resorption, three-dimensional imaging, clinical trial, dental implant, maxilla, bone healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- ITI Foundation
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Device: Cone beam computed tomography (CBCT)One group observation study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | All study participants |
Primary outcome
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.
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.
1 secondary outcome
Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing.
Time frame: At baseline and 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Results publication: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Results publication: PubMed 12956657Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.
- Results publication: PubMed 17092218Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Tissue modeling following implant placement in fresh extraction sockets. Clin Oral Implants Res. 2006 Dec;17(6):615-24. doi: 10.1111/j.1600-0501.2006.01317.x.
- Results publication: PubMed 19515033Araujo MG, Lindhe J. Ridge alterations following tooth extraction with and without flap elevation: an experimental study in the dog. Clin Oral Implants Res. 2009 Jun;20(6):545-9. doi: 10.1111/j.1600-0501.2008.01703.x.
- Results publication: PubMed 21320168Januario AL, Duarte WR, Barriviera M, Mesti JC, Araujo MG, Lindhe J. Dimension of the facial bone wall in the anterior maxilla: a cone-beam computed tomography study. Clin Oral Implants Res. 2011 Oct;22(10):1168-1171. doi: 10.1111/j.1600-0501.2010.02086.x. Epub 2011 Feb 15.
- Results publication: PubMed 18353082Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler M. Tissue alterations after tooth extraction with and without surgical trauma: a volumetric study in the beagle dog. J Clin Periodontol. 2008 Apr;35(4):356-63. doi: 10.1111/j.1600-051X.2008.01209.x.
- Results publication: PubMed 18983313Fickl S, Zuhr O, Wachtel H, Bolz W, Huerzeler MB. Hard tissue alterations after socket preservation: an experimental study in the beagle dog. Clin Oral Implants Res. 2008 Nov;19(11):1111-8. doi: 10.1111/j.1600-0501.2008.01575.x.
- Results publication: PubMed 12956475Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
- Derived from this study: PubMed 26130259Chappuis V, Engel O, Shahim K, Reyes M, Katsaros C, Buser D. Soft Tissue Alterations in Esthetic Postextraction Sites: A 3-Dimensional Analysis. J Dent Res. 2015 Sep;94(9 Suppl):187S-93S. doi: 10.1177/0022034515592869. Epub 2015 Jun 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chappuis principal investigator
Dep. Oral surgery and Stomatology, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dimensional Alterations, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in bone loss (time frame: 2-, 4-, 6-, 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403700, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.