Comparing the Secondary Stability of Dental Implants: Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla

December 4, 2014 updated by: Elhassan Mohamed Elsayed Mostafa Mossad, Cairo University

Split Mouth Clinical Study to Compare the Secondary Stability of Dental Implants Using Immediate Gradual Loading Versus Early Loading Protocol in Posterior Maxilla. A Randomized Controlled Trial

The aim of this split mouth study is to compare which method is better in reducing bone loss and healing times following implants. Specifically, the two methods investigated will be immediate gradual loading and early loading protocol.

Research Hypothesis Immediate gradual loading using gingival formers is superior to early loading protocols in improving bone quality and thus reducing the healing time.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

These two methods (gradual loading and early loading) will both be used in implants patients with the aim to compare which protocol leads to a better outcome for the patient.

A 'better outcome' is defined as the method, which leads to the least crestal bone loss, and the fastest healing time.

Immediate gradually loaded side: will include transmucosal healing of dental implants using gingival formers which will be replaced every 2 weeks by consequent larger size gingival former.i.e. at surgery time the implants will receive 2 mm height gingival former which will be swapped by 3 mm, 4 mm, 5 mm and the last is 6 mm

early loaded side: implants will be submerged from the surgery time till loading time (2 month).

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of oral & Dental Medicine. Cairo University
        • Contact:
        • Contact:
          • Mohamed kashaba, lecturer (PHD)
          • Phone Number: 00201227754765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. Patients with bilateral Partial or complete edentulous areas in maxillary premolar/molar region.
  2. Free medical history.
  3. Enough bone quantity.
  4. Enough keratinized mucosa

Exclusion criteria

  1. Systemic disease.
  2. Irradiated bone (radiotherapy).
  3. Heavy smoking habit.
  4. Patients undergoing long-term immunosuppressive therapy.
  5. Atrophic ridges.
  6. Presence of any local bony lesion.
  7. Presence of mandibular parafunctional habits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: implant A
will include implants with immediate progressive loading using gingival formers of different sizes
Procedure: immediate progressive loading using gingival formers

Implant placement will be 1 mm subcrestally, and it will receive transmucosal healing using gingival former.

The gingival former will be replaced every 2 weeks by consequent larger size gingival former (at surgery time group A will receive 2 mm height gingival former which will be swapped by,3 mm, 4 mm and the last is 5 mm).
Other: implant B
The implants will remain submerged from surgery time till loading time 2 month.(submerged healing)
Procedure: submerged healing
the implant placement will be 1 mm subcrestally, and it will receive unloaded healing.(submerged healing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondary stability of dental implant (ISQ Osstell Mentol)
Time Frame: 2 month
ISQ Osstell Mentol
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone loss using Periapical Radiographic (Long Cone Paralleling technique)
Time Frame: 2 month
using Periapical Radiographic (Long Cone Paralleling technique)
2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: elhassan mossad, oral surgeon, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • immediate_early_loading

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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