NCT06334081

Brief Summary

Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
active not 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

June 29, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 21, 2024

Last Update Submit

March 21, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • bone density measurement

    cbct will be done to evaluate difference in bone density

    6 month

  • marginal bone loss

    cbct will be done to evaluate marginal bone loss

    6 month

Study Arms (2)

Group A dental implant placement by undersized drilling technique.

EXPERIMENTAL

8 dental implants placed in the healed alveolar posterior maxillary ridge using undersized drilling technique

Procedure: undersized drilling technique

Group B dental implant placement by single drilling technique

EXPERIMENTAL

8 dental implants placed in the healed alveolar posterior maxillary ridge using singledrilling technique

Procedure: single drilling technique

Interventions

In group A The implant site preparation was made according to the protocol of the manufacturer except that the final drill was omitted. The drilling was done using a low speed reduction, high torque with coolant contra-angle hand piece with surgical motor unit. Speed of drilling was 800-1200 rpm.

Group A dental implant placement by undersized drilling technique.

In group B The implant bed was prepared using the new specially designed drills. First, the use of the guide drill of length 3.5mm with speed of 800 rpm and torque of 35 nm, then the use of the one drill of the same diameter of the selected implant size to the full length of the osteotomy site.

Group B dental implant placement by single drilling technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with missed one or more posterior maxillary tooth.
  • Be older than 18 years and of residual bone height more than10 mm.
  • Patients with good oral hygiene and willing to participate in the follow-up sessions.
  • Patients with adequate mesio-distal width and inter-arch space.
  • Patients without any para-functional habits such as clenching and bruxism.

You may not qualify if:

  • Patients whose proposed surgical site had any pathological lesion or root tips.
  • Drug or alcohol abuse.
  • Patients with uncontrolled systemic diseases.
  • Pregnant patients.
  • Tobacco use more than fourteen cigarettes daily.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heba Elsheikh

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of oral and maxillofacial surgery

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 27, 2024

Study Start

June 29, 2023

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations