RecessionNCT01346345
Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors
An observational study of Recession, run by Dr.Suzanne Caudry Implant Dentistry and Periodontics at 1 site in Canada.
Trial summary
Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary laterals and mandibular incisors Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recession
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to May 2015
- 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: Subjects for this study will be recruited from the practices of the six study centers (Dr. Caudry + 5 centers from the North American PEERS group) within a period of eighteen months from commencement of the study. A total of sixty subjects (ten per center) of any gender and race aged 18 and older will be accepted provided they meet the inclusion and exclusion criteria (see page 6). Dental implants for permanent tooth replacement are not indicated for use in those under the age of 18. Vulnerable subjects will not be included.
Who may be able to join
- Capacity to provide written informed consent to participate in the study.
- 18 years or older
- Site requirements:
- Missing one or both maxillary lateral incisors (if missing both, then both sites must be used in the study) or Single missing mandibular incisor or Two missing mandibular incisors, not adjacent to one another (both sites must be used in the study) Aside from the missing teeth specified above, all other teeth in the sextant must be present.
- A minimum of premolar occlusion is required. A minimum mesio-distal and buccal-lingual distance of 5mm is required
Who cannot join
- Rampant caries or unstable periodontal disease of the remaining dentition.
- Any systemic or local disease or condition that may compromise post-operative healing.
- Long-term use of systemic corticosteroids or other medications that may compromise post-operative healing.
- Present alcohol and/or drug abuse.
- Unable or unwilling to return for follow-up exams over a 3 year period.
- Pregnancy or lactation at time of enrollment.
- Smokers will be excluded from the subject pool.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Suzanne Caudry PhD DDS MSc Perio Implant Dentistry and Periodontics
Toronto, Ontario, M5R 3K4
About this study
Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary laterals and mandibular incisors
Read the detailed description
PURPOSE OF THE STUDY:
The purpose of this research study is to examine the aesthetics (the appearance of the implanted tooth and gums) as well as the soft tissue loss over a three-year period. This study involves replacing a missing small front tooth with a dental implant, abutment, and crown. A titanium dental implant acts as the replacement for a tooth root. An abutment is made of titanium which is either gold or silver in color and cannot be seen; but may affect the way the gum looks. An abutment is the component that attaches the crown to the implant post. A crown (which acts as the tooth replacement) is made of metal and/or porcelain and attaches over the abutment.
The dental implant and the abutments used in this study have been approved by Health Canada and the U.S. Food and Drug Administration (FDA) for the use of replacing the small teeth in the front of the mouth.
The abutment is made in two colors (either gold or silver) and you cannot choose. For each subject this is decided by chance. You will have an equal chance of getting a gold or silver-colored attachment. You will know which color the abutment will be once you have consented to be in the study and registered. You will know the color of the abutment before the implant is placed. The abutment is covered by the crown.
You will be in this study for about three years. There will be approximately 60 subjects who will participate in this study in different centres, in Canada and the USA.
- Conditions
- Recession
- Keywords
- Recession
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession
The Astra Tech 3.0 mm 2 piece implant can be placed and restored in a 5 mm or greater bone space for a mandibular incisor or maxillary lateral incisor site (minimum 5 mm mesio-distal [side to side] bone width and 5mm bucco-lingual [front to back] bone width) without exhibiting recession of the soft tissue (gingival margin or the interproximal papillae).
Measured: every 12 months for 3 years
Secondary outcomes (1)
Esthetic parameter Scores
Esthetic parameter scores will be higher when the Atlantis Gold Hue titanium abutment is used in comparison to the Atlantis titanium abutment.
Measured: every 12 months up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecessionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.Suzanne Caudry Implant Dentistry and Periodontics
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Suzanne D Caudry, DDS PhD, Principal investigator, Implant Dentistry and Periodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346345
- Sponsor's protocol ID
- WIRB® Protocol #20101573
- Status last verified
- Apr 2011
- First submitted
- 29 Apr 2011
- Last updated
- 3 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Evaluation of Two Piece 3mm Implants for Single Tooth Replacement of Maxillary Laterals and Mandibular Incisors
- ClinicalTrials.gov ID
- NCT01346345
- Acronym / sponsor ID
- WIRB® Protocol #20101573
- Conditions
- Recession
- Keywords
- Recession
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr.Suzanne Caudry Implant Dentistry and PeriodonticsUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 3 May 2011 (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.
Aesthetic evaluation of two piece 3mm implants for single tooth replacement of maxillary laterals and mandibular incisors
Detailed description
PURPOSE OF THE STUDY:
The purpose of this research study is to examine the aesthetics (the appearance of the implanted tooth and gums) as well as the soft tissue loss over a three-year period. This study involves replacing a missing small front tooth with a dental implant, abutment, and crown. A titanium dental implant acts as the replacement for a tooth root. An abutment is made of titanium which is either gold or silver in color and cannot be seen; but may affect the way the gum looks. An abutment is the component that attaches the crown to the implant post. A crown (which acts as the tooth replacement) is made of metal and/or porcelain and attaches over the abutment.
The dental implant and the abutments used in this study have been approved by Health Canada and the U.S. Food and Drug Administration (FDA) for the use of replacing the small teeth in the front of the mouth.
The abutment is made in two colors (either gold or silver) and you cannot choose. For each subject this is decided by chance. You will have an equal chance of getting a gold or silver-colored attachment. You will know which color the abutment will be once you have consented to be in the study and registered. You will know the color of the abutment before the implant is placed. The abutment is covered by the crown.
You will be in this study for about three years. There will be approximately 60 subjects who will participate in this study in different centres, in Canada and the USA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects for this study will be recruited from the practices of the six study centers (Dr. Caudry + 5 centers from the North American PEERS group) within a period of eighteen months from commencement of the study. A total of sixty subjects (ten per center) of any gender and race aged 18 and older will be accepted provided they meet the inclusion and exclusion criteria (see page 6). Dental implants for permanent tooth replacement are not indicated for use in those under the age of 18. Vulnerable subjects will not be included.
Key inclusion criteria (5 listed)
- Capacity to provide written informed consent to participate in the study.
- 18 years or older
- Missing one or both maxillary lateral incisors (if missing both, then both sites must be used in the study) or Single missing mandibular incisor or Two missing mandibular incisors, not adjacent to one another (both sites must be used in the study) Aside from the missing teeth specified above, all other teeth in the sextant must be present.
- A minimum of premolar occlusion is required. A minimum mesio-distal and buccal-lingual distance of 5mm is required
Key exclusion criteria (7 listed)
- Rampant caries or unstable periodontal disease of the remaining dentition.
- Any systemic or local disease or condition that may compromise post-operative healing.
- Long-term use of systemic corticosteroids or other medications that may compromise post-operative healing.
- Present alcohol and/or drug abuse.
- Unable or unwilling to return for follow-up exams over a 3 year period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recession
Time frame: every 12 months for 3 years
The Astra Tech 3.0 mm 2 piece implant can be placed and restored in a 5 mm or greater bone space for a mandibular incisor or maxillary lateral incisor site (minimum 5 mm mesio-distal [side to side] bone width and 5mm bucco-lingual [front to back] bone width) without exhibiting recession of the soft tissue (gingival margin or the interproximal papillae).
1 secondary outcome
Esthetic parameter Scores
Time frame: every 12 months up to three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
Related trials for Recession
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Association Between Peri-implant Soft Tissue Thickness and Midfacial Marginal Mucosal Recession
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
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Comparative Study Of Combined Recession-Resection And Fenestration of Superior Rectus Muscle for Treatment of Dissociated Vertical Deviation
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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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.
Dr. Suzanne D Caudry, DDS PhD principal investigator
Implant Dentistry and Periodontics
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 Recession, run by Dr.Suzanne Caudry Implant Dentistry and Periodontics at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 3 May 2011. 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 Canada. 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?
Results are not available in the source record.
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?
Recession (time frame: every 12 months for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2011.