Single Tooth LostPhase 2NCT04075383
Immediate and Early Single Dental Implants
A Phase 2 study testing immediate dental implant and immediate-delayed dental implant in people with Single Tooth Lost and Dental Implant, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The objective of the research project will be to compare immediate and early unitary implants for the rehabilitation of missing teeth in the upper aesthetic region. A randomized controlled trial will be conducted in parallel with 120 individuals (60 per group) who are above 18 years of age, periodontally healthy, and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Tooth Lost, Dental Implant
- What is being tested?
- immediate dental implant and immediate-delayed dental implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Jun 2019to 22 Jun 2024
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients above 18 years old who require only one single implant in the upper aesthetic area between the second premolars will be included.
- The region from which the tooth will be extracted should have bone quality and quantity compatible with implant placement with a minimum diameter and length of 3.0 mm and 8.0 mm, respectively.
Who cannot join
- Who present compromise immunology of any nature;
- Who have been exposed to head and neck radiotherapy;
- Who have uncontrolled diabetes (glycated hemoglobin above 6.5 mg/dL);
- Who present active periodontitis, defined by the presence of bleeding on probing >10% and probing depth and clinical attachment loss > 4mm;
- Who have performed or are being treated with intravenous bisphosphonates.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Alex Haas
Porto Alegre, Rio Grande do Sul, 90630080
Alex N Haas, 555191222377, alexnhaas@gmail.com
About this study
Official title: Immediate and Immediate-delayed Implants in the Esthetic Area: 12-months Randomized Controlled Trial
The objective of the research project will be to compare immediate and early unitary implants for the rehabilitation of missing teeth in the upper aesthetic region. A randomized controlled trial will be conducted in parallel with 120 individuals (60 per group) who are above 18 years of age, periodontally healthy, and who need to perform only one unit implant in the upper aesthetic region between the second premolars. In the immediate implant group, the tooth will be extracted in a minimally traumatic manner and the implant will be installed immediately after the fresh alveolus. Bovine bone replacement will be inserted into the gap between implant and vestibular wall of the alveolus, and an immediate temporary will be installed immediately. The provisional will be maintained for 3 months when the definitive crown will be made. In the early implant group, the tooth will be extracted, and after 2 months the implant will be installed with the use of bovine bone substitute to restore the buccal bone contour. The implant will be submerged, and 3 months of osseointegration will be performed reopening and final crown making. In both groups, the individuals will be followed for 1 year after the installation of the definitive crown. The outcomes evaluated will be patient satisfaction (main outcome), gingival phenotype, visible plaque, depth of probing, submucosal bleeding, proximal radiographic bone level, tomographic vestibular bone volume, perimplant clinical aesthetic indexes (Esthetic Pink Score and Papillary Index), evaluation three-dimensional tissue from intra-oral scanning and 3D printing, implant-related quality of life, and early and late implantation failures. Linear and logistic models of generalized estimating equations that take into account the longitudinal character of the study will be used for data analysis.
- Conditions
- Single Tooth Lost, Dental Implant
- Being tested
- immediate dental implant, immediate-delayed dental implant
- Keywords
- dental implant, esthetics, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate dental implantProcedure or surgery
Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.
immediate-delayed dental implantProcedure or surgery
Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| immediate dental implant | Other | The implant is installed immediately after tooth extraction. Receives: Procedure: immediate dental implant |
| immediate-delayed dental implant | Other | The implant is installed 8 weeks after tooth extraction. Receives: Procedure: immediate-delayed dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction: questionnaire
satisfaction with treatments by questionnaire in a VAS scale
Measured: Up to 24 months
tridimensional tissue changes
3D measurements obtained in oral scanning
Measured: Up to 24 months
Buccal bone level
CBCT analysis of the buccal bone
Measured: Up to 24 months
Secondary outcomes (7)
Pink esthetic score
Evaluation of the clinical esthetic outcome of soft tissues in 7 parameters recorded from 0 to 2, summing up a total of 14 points
Measured: Up to 24 months
White esthetic score
Evaluation of the clinical esthetic outcome of prosthetic crowns recorded from 0 to 2, summing up a total of 14 points
Measured: Up to 24 months
Implant failure
Failure defined as loss of implant
Measured: Up to 24 months
Oral health related quality of life: OHIP-14
Questionnaire assessing 14 questions of quality of life in a likert scale summing up a total of 48 points
Measured: Up to 24 months
dental plaque
Plaque accumulation at the crowns
Measured: Up to 24 months
Pocket depth
Measured in millimetres
Measured: Up to 24 months
Bleeding
Bleeding after probing
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start22 Jun 2019
- Primary completion22 Jun 2024 (estimated)
- Study completion22 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Tooth LostStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled parallel clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Nogueira Haas, Federal University of Rio Grande do Sul
- Investigators
- Alex Haas, PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075383
- Sponsor's protocol ID
- 11851319.9.0000.5347
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Immediate-delayed Implants in the Esthetic Area: 12-months Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04075383
- Acronym / sponsor ID
- 11851319.9.0000.5347
- Conditions
- Single Tooth Lost, Dental Implant
- Keywords
- dental implant, esthetics, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 22 Jun 2019 (actual)
- Primary completion
- 22 Jun 2024 (estimated)
- Study completion
- 22 Jun 2024 (estimated)
- First posted
- 30 Aug 2019 (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.
The objective of the research project will be to compare immediate and early unitary implants for the rehabilitation of missing teeth in the upper aesthetic region. A randomized controlled trial will be conducted in parallel with 120 individuals (60 per group) who are above 18 years of age, periodontally healthy, and who need to perform only one unit implant in the upper aesthetic region between the second premolars. In the immediate implant group, the tooth will be extracted in a minimally traumatic manner and the implant will be installed immediately after the fresh alveolus. Bovine bone replacement will be inserted into the gap between implant and vestibular wall of the alveolus, and an immediate temporary will be installed immediately. The provisional will be maintained for 3 months when the definitive crown will be made. In the early implant group, the tooth will be extracted, and after 2 months the implant will be installed with the use of bovine bone substitute to restore the buccal bone contour. The implant will be submerged, and 3 months of osseointegration will be performed reopening and final crown making. In both groups, the individuals will be followed for 1 year after the installation of the definitive crown. The outcomes evaluated will be patient satisfaction (main outcome), gingival phenotype, visible plaque, depth of probing, submucosal bleeding, proximal radiographic bone level, tomographic vestibular bone volume, perimplant clinical aesthetic indexes (Esthetic Pink Score and Papillary Index), evaluation three-dimensional tissue from intra-oral scanning and 3D printing, implant-related quality of life, and early and late implantation failures. Linear and logistic models of generalized estimating equations that take into account the longitudinal character of the study will be used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| immediate dental implant | Other | Procedure: immediate dental implantThe implant is installed immediately after tooth extraction. |
| immediate-delayed dental implant | Other | Procedure: immediate-delayed dental implantThe implant is installed 8 weeks after tooth extraction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above 18 years old who require only one single implant in the upper aesthetic area between the second premolars will be included.
- The region from which the tooth will be extracted should have bone quality and quantity compatible with implant placement with a minimum diameter and length of 3.0 mm and 8.0 mm, respectively.
Key exclusion criteria (5 listed)
- Who present compromise immunology of any nature;
- Who have been exposed to head and neck radiotherapy;
- Who have uncontrolled diabetes (glycated hemoglobin above 6.5 mg/dL);
- Who present active periodontitis, defined by the presence of bleeding on probing >10% and probing depth and clinical attachment loss > 4mm;
- Who have performed or are being treated with intravenous bisphosphonates.
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 |
|---|---|---|
| immediate dental implantReplacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction. | Procedure or surgery | immediate dental implant |
| immediate-delayed dental implantReplacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction. | Procedure or surgery | immediate-delayed dental implant |
Primary outcome
patient satisfaction: questionnaire
Time frame: Up to 24 months
satisfaction with treatments by questionnaire in a VAS scale
tridimensional tissue changes
Time frame: Up to 24 months
3D measurements obtained in oral scanning
Buccal bone level
Time frame: Up to 24 months
CBCT analysis of the buccal bone
7 secondary outcomes
Pink esthetic score
Time frame: Up to 24 months
White esthetic score
Time frame: Up to 24 months
Implant failure
Time frame: Up to 24 months
Oral health related quality of life: OHIP-14
Time frame: Up to 24 months
dental plaque
Time frame: Up to 24 months
Pocket depth
Time frame: Up to 24 months
Bleeding
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Alex Haas, PhD study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing immediate dental implant and immediate-delayed dental implant in people with Single Tooth Lost and Dental Implant, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Alex Haas, PhD (555133085318, alexnhaas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction: questionnaire (time frame: Up to 24 months). The study lists 3 primary outcomes in all. 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 5 Apr 2022.