Esthetic Outcomes of Single Immediate Implant Placement

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435706
• Other study ID #: AAAI1840
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: August 9, 2016

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 protocol.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 9, 2016
• Est. primary completion date: August 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss, Alveolar
• Gingival Recession

Intervention

Procedure:
• Flapless immediate implant placement
Experimental group: No elevation of flap prior to immediate implant placement
• Flap assisted immediate implant placement
Control group: Flap will be elevated prior to immediate implant placement

Device:
• Implant and temporary crown
Both groups receive this intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline		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	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.	Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
Secondary	Change in Interproximal Crestal Bone Levels		Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months