Clinical trial NCT02435706: Esthetic Outcomes of Single Immediate Implant Placement
Official title: Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Bone Loss, Alveolar
Keywords: Dental implants
surgical flap
esthetics
alveolar process
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Single non-restorable tooth in the anterior maxilla
* Intact buccal plate or \<5mm fenestration

Exclusion Criteria:

* Pregnancy
* Current smokers \>10 cigarettes/day
* Parafunctional habits
* Malocclusion or intent of orthodontic therapy in the future
* Severe periodontal disease

Primary outcomes:
measure: Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
timeFrame: 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:
measure: Change in Buccal Horizontal Ridge Dimensions
timeFrame: Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
measure: Change in Interproximal Crestal Bone Levels
timeFrame: Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Elena Sanz Miralles, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lee 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.