NCT06985511

Brief Summary

This study aims to determine the differences in implant stability and measurement of bone loss near implants between two different healing approaches used for teeth replacement in the front part of the upper jaw.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

January 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

May 15, 2025

Last Update Submit

May 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Marginal Bone Loss

    Cone beam computed tomography (CBCT) scans were obtained at the time of final restoration and post-placement. Measurements were made (in mm) from the implant platform to the most coronal bone level using OnDemand3D software. Each scan was oriented to align the implant with the axial plane. Measurements were performed by a single calibrated examiner to a precision of 0.01 mm.

    up to 12 months

  • Implant stability

    Implant Stability Quotient (ISQ) values were measured using Osstell. To ensure accuracy, the probe was positioned at a 90° angle and 3 mm above soft tissue level, as recommended in previous protocols. Osstell's patented technology uses the ISQ scale, with values ranging from 1 to 100, where higher values indicate greater stability

    up to 12 months

Study Arms (2)

Immediate implant placement

EXPERIMENTAL
Procedure: Immediate implant placement

Early implant placement

ACTIVE COMPARATOR
Procedure: Early implant placement

Interventions

Tooth extraction was performed atraumatically on one side, followed by immediate implant placement, right after extraction.

Immediate implant placement

The tooth was extracted, and the implant was placed four weeks later (early placement).

Early implant placement

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of unrestorable bilateral anterior teeth.
  • Harmonious gingival contour and thick gingival phenotype
  • Minimum 4 mm of apical bone and 2 mm of intact labial plate
  • Absence of periapical pathology

You may not qualify if:

  • Systemic conditions affecting osseointegration or healing
  • Active oral infections or periodontal disease
  • Dehiscence or fenestration defects
  • Poor oral hygiene or heavy smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: split-mouth design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Prosthodontics

Study Record Dates

First Submitted

May 15, 2025

First Posted

May 22, 2025

Study Start

January 10, 2023

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations