Gingival RecessionNCT03558282
Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
An observational study of Gingival Recession, run by University of Michigan at 1 site in United States.
Trial summary
A single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Recession Observation and Crown Contour Observation
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 22 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who had a single implant restoration in the maxillary anterior position with sufficient baseline data will be recruited for this study.
Who may be able to join
- Subjects 18 years old or older
- One immediate maxillary implant placement with 2 adjacent neighboring teeth
- Available pre-surgery model
- Radiographic documentation (either peri-apical x-rays or CBCT)
- Have final restoration for at least 6 months.
Who cannot join
- Are under 18 years of age.
- Are unwilling or unable to read and sign this informed consent document.
- Have any medical conditions that we believe may influence the outcome of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
A single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss.
The primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.
Read the detailed description
Facial mucosal recession still poses a threat to long-term success of implant therapy especially esthetic appearance. To study the timing and extent of mucosal recession and the associated risks, a prospective study is strategically important. This will allow the collection of valuable longitudinal data about facial mucosal level changes, peri-implant tissue dimensions, and implant/restoration parameters that are considered critical for determining the mucosal level. Forty adult patients who meet the inclusion criteria will be recruited to participate in this study. Patients that had an implant crown placed a minimum time frame of 6 months and have existing relevant clinical data (mucosal level and thickness, radiographs, cone beam computed tomogram (CBCT) scans, study casts and intra-oral photographs) at baseline and if possible at other follow-up visits will be invited to participate in this study. Patients that volunteer to be screened will not be examined for study eligibility until an informed consent has been obtained. Patient information will be protected according to HIPAA. The enrolled subjects will have research measurements taken, an ultrasound scan, intraoral photos and an impression of the arch including the study implant. One dental cone beam computed tomography (CBCT) scan will be taken to evaluate the implant position in relation to the alveolar ridge and to evaluate relative bone quality. The primary outcome will analyze the changes in the facial mucosal level, by superimposing the digital images of the stone models that were taken previously. On ultrasound images, peri-implant tissue parameters, implant positions, restoration contour, etc., will be measured and recorded. The primary outcome will then be equated with clinical and radiographic readings, and ultrasound parameters, along with timing of provisionalization or final restoration, in regression analysis to identify factors related to facial mucosal recession.
- Conditions
- Gingival Recession
- Being tested
- Recession Observation, Crown Contour Observation
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recession ObservationOther
Soft tissue measurements
Crown Contour ObservationDiagnostic test
Ultrasound measures of implant crown contour.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary Anterior Implant | Subjects who have a single implant restoration in the maxillary anterior position with sufficient baseline data. Recession observation and crown contour observation of the implant will be completed. Receives: Other: Recession Observation; Diagnostic Test: Crown Contour Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal recession on the tested implant
It is a one-time measurement (this study is only one-time visit) within the study timeframe, measured from a reference, adjacent tooth landmark, to the mucosal margin of the implant.
Measured: At least 12 months following implant placement.
Secondary outcomes (1)
Crown contour of the tested implant
It is a one-time measurement (this study is only one-time visit) within the study timeframe. It is measured on ultrasound images. It is the angle between the tangent line of the implant crown and implant fixture.
Measured: At least 12 months following implant placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start7 Aug 2018
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Kuwait Foundation for the Advancement of Sciences
- Responsible party
- Principal investigator, Hsun-Liang Chan, University of Michigan
- Investigators
- Hsun-Liang Chan, DDS, MS, Principal investigator, Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558282
- Sponsor's protocol ID
- HUM00139630
- Status last verified
- Feb 2019
- First submitted
- 18 May 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abduo J. Axial Tooth Contour Alteration Following Fixed Prosthodontic Treatment. Eur J Prosthodont Restor Dent. 2014 Dec;22(4):174-82.
PubMed 26466442Berglundh T, Abrahamsson I, Welander M, Lang NP, Lindhe J. Morphogenesis of the peri-implant mucosa: an experimental study in dogs. Clin Oral Implants Res. 2007 Feb;18(1):1-8. doi: 10.1111/j.1600-0501.2006.01380.x.
PubMed 17224016Bichacho N, Landsberg CJ. Single implant restorations: prosthetically induced soft tissue topography. Pract Periodontics Aesthet Dent. 1997 Sep;9(7):745-52; quiz 754.
PubMed 9743681Canullo L, Tallarico M, Radovanovic S, Delibasic B, Covani U, Rakic M. Distinguishing predictive profiles for patient-based risk assessment and diagnostics of plaque induced, surgically and prosthetically triggered peri-implantitis. Clin Oral Implants Res. 2016 Oct;27(10):1243-1250. doi: 10.1111/clr.12738. Epub 2015 Nov 20.
PubMed 26584716Chan HL, Garaicoa-Pazmino C, Suarez F, Monje A, Benavides E, Oh TJ, Wang HL. Incidence of implant buccal plate fenestration in the esthetic zone: a cone beam computed tomography study. Int J Oral Maxillofac Implants. 2014 Jan-Feb;29(1):171-7. doi: 10.11607/jomi.3397.
PubMed 24451868Chan HL, Sinjab K, Chung MP, Chiang YC, Wang HL, Giannobile WV, Kripfgans OD. Non-invasive evaluation of facial crestal bone with ultrasonography. PLoS One. 2017 Feb 8;12(2):e0171237. doi: 10.1371/journal.pone.0171237. eCollection 2017.
PubMed 28178323Chan HL, Wang HL, Fowlkes JB, Giannobile WV, Kripfgans OD. Non-ionizing real-time ultrasonography in implant and oral surgery: A feasibility study. Clin Oral Implants Res. 2017 Mar;28(3):341-347. doi: 10.1111/clr.12805. Epub 2016 Mar 19.
PubMed 26992276Chifor R, Hedesiu M, Bolfa P, Catoi C, Crisan M, Serbanescu A, Badea AF, Moga I, Badea ME. The evaluation of 20 MHz ultrasonography, computed tomography scans as compared to direct microscopy for periodontal system assessment. Med Ultrason. 2011 Jun;13(2):120-6.
PubMed 21655538Chu SJ, Paravina RD. Periodontal-prosthodontics in contemporary practice. J Dent. 2013 Aug;41 Suppl 3:e1-2. doi: 10.1016/j.jdent.2013.06.010. No abstract available.
PubMed 23856512Cooper LF, Pin-Harry OC. "Rules of Six"--diagnostic and therapeutic guidelines for single-tooth implant success. Compend Contin Educ Dent. 2013 Feb;34(2):94-8, 100-1; quiz 102, 117.
PubMed 23556318Davarpanah M, Martinez H, Tecucianu JF. Apical-coronal implant position: recent surgical proposals. Technical note. Int J Oral Maxillofac Implants. 2000 Nov-Dec;15(6):865-72.
PubMed 11151587De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.
PubMed 26373422Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
PubMed 25495683Dierens M, de Bruecker E, Vandeweghe S, Kisch J, de Bruyn H, Cosyn J. Alterations in soft tissue levels and aesthetics over a 16-22 year period following single implant treatment in periodontally-healthy patients: a retrospective case series. J Clin Periodontol. 2013 Mar;40(3):311-8. doi: 10.1111/jcpe.12049. Epub 2013 Jan 9.
PubMed 23297745Du JK, Li HY, Wu JH, Lee HE, Wang CH. Emergence angles of the cementoenamel junction in natural maxillary anterior teeth. J Esthet Restor Dent. 2011 Dec;23(6):362-9. doi: 10.1111/j.1708-8240.2011.00471.x. Epub 2011 Sep 20.
PubMed 22142293
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
- ClinicalTrials.gov ID
- NCT03558282
- Acronym / sponsor ID
- HUM00139630
- Conditions
- Gingival Recession
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Kuwait Foundation for the Advancement of Sciences
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- 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.
A single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss.
The primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.
Detailed description
Facial mucosal recession still poses a threat to long-term success of implant therapy especially esthetic appearance. To study the timing and extent of mucosal recession and the associated risks, a prospective study is strategically important. This will allow the collection of valuable longitudinal data about facial mucosal level changes, peri-implant tissue dimensions, and implant/restoration parameters that are considered critical for determining the mucosal level. Forty adult patients who meet the inclusion criteria will be recruited to participate in this study. Patients that had an implant crown placed a minimum time frame of 6 months and have existing relevant clinical data (mucosal level and thickness, radiographs, cone beam computed tomogram (CBCT) scans, study casts and intra-oral photographs) at baseline and if possible at other follow-up visits will be invited to participate in this study. Patients that volunteer to be screened will not be examined for study eligibility until an informed consent has been obtained. Patient information will be protected according to HIPAA. The enrolled subjects will have research measurements taken, an ultrasound scan, intraoral photos and an impression of the arch including the study implant. One dental cone beam computed tomography (CBCT) scan will be taken to evaluate the implant position in relation to the alveolar ridge and to evaluate relative bone quality. The primary outcome will analyze the changes in the facial mucosal level, by superimposing the digital images of the stone models that were taken previously. On ultrasound images, peri-implant tissue parameters, implant positions, restoration contour, etc., will be measured and recorded. The primary outcome will then be equated with clinical and radiographic readings, and ultrasound parameters, along with timing of provisionalization or final restoration, in regression analysis to identify factors related to facial mucosal recession.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maxillary Anterior Implant | – | Other: Recession Observation, Diagnostic Test: Crown Contour ObservationSubjects who have a single implant restoration in the maxillary anterior position with sufficient baseline data. Recession observation and crown contour observation of the implant will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who had a single implant restoration in the maxillary anterior position with sufficient baseline data will be recruited for this study.
Key inclusion criteria (5 listed)
- Subjects 18 years old or older
- One immediate maxillary implant placement with 2 adjacent neighboring teeth
- Available pre-surgery model
- Radiographic documentation (either peri-apical x-rays or CBCT)
- Have final restoration for at least 6 months.
Key exclusion criteria (3 listed)
- Are under 18 years of age.
- Are unwilling or unable to read and sign this informed consent document.
- Have any medical conditions that we believe may influence the outcome of the study.
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 |
|---|---|---|
| Recession ObservationSoft tissue measurements | Other | Maxillary Anterior Implant |
| Crown Contour ObservationUltrasound measures of implant crown contour. | Diagnostic test | Maxillary Anterior Implant |
Primary outcome
Mucosal recession on the tested implant
Time frame: At least 12 months following implant placement.
It is a one-time measurement (this study is only one-time visit) within the study timeframe, measured from a reference, adjacent tooth landmark, to the mucosal margin of the implant.
1 secondary outcome
Crown contour of the tested implant
Time frame: At least 12 months following implant placement.
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 15 Feb 2019.
- Background: PubMed 26466442Abduo J. Axial Tooth Contour Alteration Following Fixed Prosthodontic Treatment. Eur J Prosthodont Restor Dent. 2014 Dec;22(4):174-82.
- Background: PubMed 17224016Berglundh T, Abrahamsson I, Welander M, Lang NP, Lindhe J. Morphogenesis of the peri-implant mucosa: an experimental study in dogs. Clin Oral Implants Res. 2007 Feb;18(1):1-8. doi: 10.1111/j.1600-0501.2006.01380.x.
- Background: PubMed 9743681Bichacho N, Landsberg CJ. Single implant restorations: prosthetically induced soft tissue topography. Pract Periodontics Aesthet Dent. 1997 Sep;9(7):745-52; quiz 754.
- Background: PubMed 26584716Canullo L, Tallarico M, Radovanovic S, Delibasic B, Covani U, Rakic M. Distinguishing predictive profiles for patient-based risk assessment and diagnostics of plaque induced, surgically and prosthetically triggered peri-implantitis. Clin Oral Implants Res. 2016 Oct;27(10):1243-1250. doi: 10.1111/clr.12738. Epub 2015 Nov 20.
- Background: PubMed 24451868Chan HL, Garaicoa-Pazmino C, Suarez F, Monje A, Benavides E, Oh TJ, Wang HL. Incidence of implant buccal plate fenestration in the esthetic zone: a cone beam computed tomography study. Int J Oral Maxillofac Implants. 2014 Jan-Feb;29(1):171-7. doi: 10.11607/jomi.3397.
- Background: PubMed 28178323Chan HL, Sinjab K, Chung MP, Chiang YC, Wang HL, Giannobile WV, Kripfgans OD. Non-invasive evaluation of facial crestal bone with ultrasonography. PLoS One. 2017 Feb 8;12(2):e0171237. doi: 10.1371/journal.pone.0171237. eCollection 2017.
- Background: PubMed 26992276Chan HL, Wang HL, Fowlkes JB, Giannobile WV, Kripfgans OD. Non-ionizing real-time ultrasonography in implant and oral surgery: A feasibility study. Clin Oral Implants Res. 2017 Mar;28(3):341-347. doi: 10.1111/clr.12805. Epub 2016 Mar 19.
- Background: PubMed 21655538Chifor R, Hedesiu M, Bolfa P, Catoi C, Crisan M, Serbanescu A, Badea AF, Moga I, Badea ME. The evaluation of 20 MHz ultrasonography, computed tomography scans as compared to direct microscopy for periodontal system assessment. Med Ultrason. 2011 Jun;13(2):120-6.
- Background: PubMed 23856512Chu SJ, Paravina RD. Periodontal-prosthodontics in contemporary practice. J Dent. 2013 Aug;41 Suppl 3:e1-2. doi: 10.1016/j.jdent.2013.06.010. No abstract available.
- Background: PubMed 23556318Cooper LF, Pin-Harry OC. "Rules of Six"--diagnostic and therapeutic guidelines for single-tooth implant success. Compend Contin Educ Dent. 2013 Feb;34(2):94-8, 100-1; quiz 102, 117.
- Background: PubMed 11151587Davarpanah M, Martinez H, Tecucianu JF. Apical-coronal implant position: recent surgical proposals. Technical note. Int J Oral Maxillofac Implants. 2000 Nov-Dec;15(6):865-72.
- Background: PubMed 26373422De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.
- Individual participant dataSharing planned: Undecided
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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.
Hsun-Liang Chan, DDS, MS principal investigator
Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
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 Gingival Recession, run by University of Michigan at 1 site in United States.
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 3 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 15 Feb 2019. 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 United States. 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?
Mucosal recession on the tested implant (time frame: At least 12 months following implant placement.). 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 NCT03558282, which also lists 44 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 15 Feb 2019.