Clinical Trials Directory

Trials / Completed

CompletedNCT02435706

Esthetic Outcomes of Single Immediate Implant Placement

Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
39 (actual)
Sponsor
Columbia University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREFlapless immediate implant placementExperimental group: No elevation of flap prior to immediate implant placement
PROCEDUREFlap assisted immediate implant placementControl group: Flap will be elevated prior to immediate implant placement
DEVICEImplant and temporary crownBoth groups receive this intervention

Timeline

Start date
2011-12-01
Primary completion
2016-08-09
Completion
2016-08-09
First posted
2015-05-06
Last updated
2019-05-03
Results posted
2019-05-03

Source: ClinicalTrials.gov record NCT02435706. Inclusion in this directory is not an endorsement.