Gingival RecessionNCT02435706
Esthetic Outcomes of Single Immediate Implant Placement
A study testing Flapless immediate implant placement, Flap assisted immediate implant placement and Implant and temporary crown in people with Gingival Recession and Bone Loss, Alveolar, run by Columbia University.
Trial summary
A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Bone Loss, Alveolar
- What is being tested?
- Flapless immediate implant placement, Flap assisted immediate implant placement and Implant and temporary crown
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to 9 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Single non-restorable tooth in the anterior maxilla
- Intact buccal plate or <5mm fenestration
Who cannot join
- Pregnancy
- Current smokers >10 cigarettes/day
- Parafunctional habits
- Malocclusion or intent of orthodontic therapy in the future
- Severe periodontal disease
About this study
Official title: Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless protocol.
Read the detailed description
In the test group, the implant will be placed according to standard protocol at a position engaging the palatal wall without elevation of a mucoperiosteal flap.
In the control group, intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the extraction site and full thickness flaps will be elevated with periosteal elevator, including the papillae. The implant will be placed according to standard protocol at a position engaging the palatal wall, and the flaps will be sutured using a combination of interrupted and mattress sutures.
In both groups, temporary restorations will be delivered immediately after implant placement provided that the implant shows primary stability and has engaged in the bone with an insertion torque of 25Ncm or more. In case of a lower insertion torque, the protocol will be abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All patients will be advised to receive a permanent restoration 6 months after surgery, if the implant is deemed to be successful.
- Conditions
- Gingival Recession, Bone Loss, Alveolar
- Being tested
- Flapless immediate implant placement, Flap assisted immediate implant placement, Implant and temporary crown
- Keywords
- Dental implants, surgical flap, esthetics, alveolar process
- Medical subject headings
- Gingival Recession, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flapless immediate implant placementProcedure or surgery
Experimental group: No elevation of flap prior to immediate implant placement
Flap assisted immediate implant placementProcedure or surgery
Control group: Flap will be elevated prior to immediate implant placement
Implant and temporary crownDevice
Both groups receive this intervention
| Study group | Role | What they receive |
|---|---|---|
| Flapless immediate implant placement group | Experimental | Flapless placement of immediate implant and temporary crown Receives: Procedure: Flapless immediate implant placement; Device: Implant and temporary crown |
| Flap assisted immediate implant placement group | Active comparator | Flap elevation prior to placement of immediate implant and temporary crown Receives: Procedure: Flap assisted immediate implant placement; Device: Implant and temporary crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
Measured: Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months
Secondary outcomes (2)
Change in Buccal Horizontal Ridge Dimensions
Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.
Measured: Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
Change in Interproximal Crestal Bone Levels
Measured: Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startDec 2011
- Primary completion9 Aug 2016
- Study completion9 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 Columbia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Sanz Miralles, Columbia University
- Investigators
- Elena Sanz Miralles, DDS, MS, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435706
- Sponsor's protocol ID
- AAAI1840
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2015
- Last updated
- 3 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data were shared with The University of Texas Science Center at Houston (Dr. Chun-Teh Lee, formerly at Columbia University) in order to pursue further analysis of the data.
Publications
Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.
PubMed 27501953Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.
PubMed 24894299
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
- ClinicalTrials.gov ID
- NCT02435706
- Acronym / sponsor ID
- AAAI1840
- Conditions
- Gingival Recession, Bone Loss, Alveolar
- Keywords
- Dental implants, surgical flap, esthetics, alveolar process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 9 Aug 2016 (actual)
- Study completion
- 9 Aug 2016 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Posted 3 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless protocol.
Detailed description
In the test group, the implant will be placed according to standard protocol at a position engaging the palatal wall without elevation of a mucoperiosteal flap.
In the control group, intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the extraction site and full thickness flaps will be elevated with periosteal elevator, including the papillae. The implant will be placed according to standard protocol at a position engaging the palatal wall, and the flaps will be sutured using a combination of interrupted and mattress sutures.
In both groups, temporary restorations will be delivered immediately after implant placement provided that the implant shows primary stability and has engaged in the bone with an insertion torque of 25Ncm or more. In case of a lower insertion torque, the protocol will be abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All patients will be advised to receive a permanent restoration 6 months after surgery, if the implant is deemed to be successful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flapless immediate implant placement group | Experimental | Procedure: Flapless immediate implant placement, Device: Implant and temporary crownFlapless placement of immediate implant and temporary crown |
| Flap assisted immediate implant placement group | Active comparator | Procedure: Flap assisted immediate implant placement, Device: Implant and temporary crownFlap elevation prior to placement of immediate implant and temporary crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single non-restorable tooth in the anterior maxilla
- Intact buccal plate or <5mm fenestration
Key exclusion criteria (5 listed)
- Pregnancy
- Current smokers >10 cigarettes/day
- Parafunctional habits
- Malocclusion or intent of orthodontic therapy in the future
- Severe periodontal disease
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 |
|---|---|---|
| Flapless immediate implant placementExperimental group: No elevation of flap prior to immediate implant placement | Procedure or surgery | Flapless immediate implant placement group |
| Flap assisted immediate implant placementControl group: Flap will be elevated prior to immediate implant placement | Procedure or surgery | Flap assisted immediate implant placement group |
| Implant and temporary crownBoth groups receive this intervention | Device | Flap assisted immediate implant placement group, Flapless immediate implant placement group |
Primary outcome
Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
Time frame: Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months
2 secondary outcomes
Change in Buccal Horizontal Ridge Dimensions
Time frame: Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
Change in Interproximal Crestal Bone Levels
Time frame: Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27501953Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.
- Background: PubMed 24894299Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.
- Individual participant dataSharing planned: Yes. De-identified data were shared with The University of Texas Science Center at Houston (Dr. Chun-Teh Lee, formerly at Columbia University) in order to pursue further analysis of the data.
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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.
Elena Sanz Miralles, DDS, MS, PhD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing Flapless immediate implant placement, Flap assisted immediate implant placement and Implant and temporary crown in people with Gingival Recession and Bone Loss, Alveolar, run by Columbia University.
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: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline (time frame: Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months). 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 NCT02435706, which also lists 2 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 3 May 2019.