NCT02761226

Brief Summary

Implants have become the preferred method of single tooth replacement these days, patients receiving implant treatments not only expect restoration of masticatory function, they also expect that the prostheses will be esthetically pleasing, easy to clean, and permanent. To maintain long-term implant stability, it is important to minimize bone loss around the implant, as well as the soft tissue atrophy that accompanies it.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
Last Updated

May 10, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

April 5, 2016

Last Update Submit

May 6, 2016

Conditions

Crestal Bone Loss

Keywords

platform switchingdental implantcrestal bone levelimplant stabilitypostoperative complication

Outcome Measures

Primary Outcomes (1)

  • crestal bone loss

    assessment crestal bone loss after 9 months after crown placement

    9 months

Secondary Outcomes (1)

  • implant stability

    9 months

Study Arms (2)

Group A (Platform Matched Design)

EXPERIMENTAL

10 Patients with missing tooth in upper posterior area will receive dental implant (implants with the same abutment diameter)

Procedure: Platform Matched Design (Group A)

Group B (intervention - Platform Switching Design)

ACTIVE COMPARATOR

10 patients with missing tooth in upper posterior area will receive dental implant (implants with smaller diameter abutment)

Procedure: Platform Switching Design (Group B)

Interventions

Platform Matched Design (Group A)PROCEDURE

10 patients with missing upper posterior teeth will receive dental implant with platform matched design (the patients will receive implant 4.2mm with same abutment diameter 4.2mm)

Also known as: group 1
Group A (Platform Matched Design)
Platform Switching Design (Group B)PROCEDURE

10 patients with missing upper posterior teeth will receive dental implant with platform switching design(the patients will receive implant 4.2mm with smaller abutment diameter 3.5 mm

Also known as: group 2
Group B (intervention - Platform Switching Design)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients older than18 yrs.
  • Patients with missing teeth in the posterior maxilla (from the 1st premolar to 2nd Molar) bilaterally in need for fixed implant-supported prosthesis.
  • Full mouth plaque score and full mouth bleeding score ˂25 %
  • Patients with adequate bone quality and quantity at the implant site
  • Patients with systematic healthy.
  • Non-smokers or those smoking ˂10 cigarettes/day
  • Patients who were cooperative, motivated, and hygiene conscious and willing to return for multiple follow-up appointments (up to 9 months after prosthetic loading).

You may not qualify if:

  • I) General:-
  • Patients with any systemic condition that may contraindicate implant therapy.
  • Patients with a history of Bisphosphonate therapy
  • Pregnant and lactating patients
  • Alcohol and drug abuse
  • Parafunctional habits that produce overload on the implant such as bruxism and clenching.
  • II) Local:-
  • Local inflammation or infection at implant site.
  • Untreated periodontitis
  • Local irradiation therapy
  • History of implant failure as well as unhealed extraction socket
  • Inadequate keratinized gingiva or thin gingival biotype.
  • Inadequate bone height or width.
  • Insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

April 5, 2016

First Posted

May 4, 2016

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-04