Overview

This trial is active, not recruiting.

Conditions gingival recession, bone loss, alveolar
Treatments flapless immediate implant placement, flap assisted immediate implant placement, implant and temporary crown
Sponsor Columbia University
Start date December 2011
End date July 2016
Trial size 39 participants
Trial identifier NCT02435706, AAAI1840

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Flapless immediate implant placement: Flapless placement of immediate implant and temporary crown
flapless immediate implant placement
No elevation of flap prior to immediate implant placement
implant and temporary crown
Standard intervention/procedure (non-experimental)
(Active Comparator)
Flap assisted immediate implant placement: Flap elevation prior to placement of immediate implant and temporary crown
flap assisted immediate implant placement
Flap will be elevated prior to immediate implant placement
implant and temporary crown
Standard intervention/procedure (non-experimental)

Primary Outcomes

Measure
Change in Gingival Margin Location on the Buccal, Mesial and Distal
time frame: Change from Baseline in Gingival Margin Location at 3, at 6 and at 12 months

Secondary Outcomes

Measure
Change in Interproximal Crestal Bone Levels
time frame: Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months
Change in Buccal Horizontal Ridge Dimensions
time frame: Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 3 to 6 months and 6 to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
Principal investigator Panos Papapanou, DDS, PhD
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 (Norton, 2004). 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 (Misch et al., 2008).
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Columbia University.