NCT06281535

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

February 6, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 6, 2024

Last Update Submit

February 24, 2024

Conditions

Keywords

early loadingconventional loading

Outcome Measures

Primary Outcomes (1)

  • Implant stability

    Degree of implant stability will be measured by Osstell device as a scale from 1 to 100

    2 and 3 months following implant placement

Study Arms (2)

Early loading group

EXPERIMENTAL

The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 2 months following implant placement.

Device: Implant loading

Conventional loading group

ACTIVE COMPARATOR

The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 3 months following implant placement.

Device: Implant loading

Interventions

Placement of abutments and final restorations either 2 months following implant placement in early loading group or 3 months in conventional loading group

Conventional loading groupEarly loading group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Officials

  • Doaa Adel-Khattab, PhD

    Associate Professor Faculty of Dentistry, Ain Shams University

    STUDY CHAIR
  • Abdel Rahman Khalaf, PhD

    Lecturer of Faculty of Dentistry, Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdel Rahman Khalaf, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 28, 2024

Study Start

February 20, 2024

Primary Completion

May 31, 2024

Study Completion

June 15, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share