Skip to main content
OpenTrials
Completed

NCT Number: NCT02435706

Esthetic Outcomes of Single Immediate Implant Placement

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingival Recession Alveolar Bone Loss Bone Diseases Bone Loss, Alveolar Bone Resorption Gingival Diseases Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flapless immediate implant placement

Procedure

Experimental group: No elevation of flap prior to immediate implant placement

Flap assisted immediate implant placement

Procedure

Control group: Flap will be elevated prior to immediate implant placement

Implant and temporary crown

Device

Both groups receive this intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Buccal Horizontal Ridge Dimensions

    Time frame: Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months

    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.

  2. Change in Interproximal Crestal Bone Levels

    Time frame: Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 6, 2015
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.