Early Versus Conventional Loading for Fully Guided Immediate Implant Placement

February 24, 2024 updated by: Doaa Adel Salah Khattab, Ain Shams University

Early Versus Conventional Loading for Fully Guided Immediate Implant Placement in Molar Sites (A Randomized Controlled Clinical Study)

Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.

Study Type

Interventional

Enrollment (Estimated)

24

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 Contact

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients age range from 20-60 years.
  • Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture.
  • Primary implant stability is above 30 Ncm.

Exclusion Criteria:

  • History or presence of severe uncontrolled systemic disease.
  • Heavy smokers (>10 cigarettes per day) or alcohol/drug abusers.
  • Poor oral hygiene.
  • Acute periapical infection.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early loading group
The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 2 months following implant placement.
Device: Implant loading
Placement of abutments and final restorations either 2 months following implant placement in early loading group or 3 months in conventional loading group
Active Comparator: Conventional loading group
The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 3 months following implant placement.
Device: Implant loading
Placement of abutments and final restorations either 2 months following implant placement in early loading group or 3 months in conventional loading group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: 2 and 3 months following implant placement
Degree of implant stability will be measured by Osstell device as a scale from 1 to 100
2 and 3 months following implant placement

Collaborators and Investigators

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

Sponsor

Ain Shams University

Collaborators

Assiut University

Investigators

  • Study Chair: Doaa Adel-Khattab, PhD, Associate Professor Faculty of Dentistry, Ain Shams University
  • Principal Investigator: Abdel Rahman Khalaf, PhD, Lecturer of Faculty of Dentistry, Assiut University

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 (Estimated)

February 20, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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