NCT06447792

Brief Summary

Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability.1 Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 2, 2024

Last Update Submit

June 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Implant survival

    The implant is present at the follow-up examination but its condition is not specified.

    3 years

Study Arms (3)

Group 1

immediately placed implants with a delayed loading protocol. Loading was performed after 3 months.

Other: Loading protocol

Group 2

immediately placed implants with a progressive loading protocol. Loading was performed after 5 weeks.

Other: Loading protocol

Group 3

immediately placed implants with an immediate loading protocol. The day of the surgery was also the day of loading.

Other: Loading protocol

Interventions

The prosthetic restoration and functional loading of the dental implant.

Group 1Group 2Group 3

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People over 25 and less than 50 years

You may qualify if:

  • fully dentulous people over 25 who complained of the mobility of 4 mandibular incisor teeth, or partially dentulous people who missed 2 mandibular central incisor teeth and had periodontally affected the neighboring lateral incisor teeth.
  • These individuals were subsequently treated with 2 implants supporting FPDs and following a delayed, progressive, or immediate loading protocol
  • Class 0 or 1 bone defects after tooth extraction, were only included in the study
  • The medical records included data regarding implant type, width, and length, surgical procedure, annual hygienist treatments, radiographs, and implant insertion date

You may not qualify if:

  • had less than 1 years of follow-up, had incomplete restorative or surgical data, had non-diagnostic radiographs, had more or less than 4 unit fixed partial denture
  • patients did not present for annual follow-up visits to evaluate oral hygiene measures or treat mechanical or technical complications.
  • Individuals with bone defects class 2, 3, 4, or 5 after mandibular lateral incisor tooth extraction were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed A. Elsawy

Al Mansurah, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Mohammed A. Elsawy, PhD

CONTACT

Mohammed T. Khater, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, Department of Prosthodontics, principle investigator

Study Record Dates

First Submitted

June 2, 2024

First Posted

June 7, 2024

Study Start

February 1, 2024

Primary Completion

August 4, 2024

Study Completion

August 20, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

For a reasonable reason after contacting the corresponding author.

Locations