NCT05960136

Brief Summary

The risk of Schneiderian membrane perforation and the postoperative complications of the sinus floor elevation surgery were evaluated for patients with and without history of COVID-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 22, 2023

Last Update Submit

July 24, 2023

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Sinus membrane perforation

    Intraoperative assessment of the incidence of sinus membrane perforation

    Duration sinus lift

Study Arms (2)

Sinus lift in patients with previous COVID-19 infection

ACTIVE COMPARATOR

Sinus floor augmentation in the posterior atrophic maxilla with delayed implant placement in patients with positive history of previous COVID-19 infection.

Procedure: Sinus lift in patients with positive COVID-19 history

Sinus lift in patients with negative history of previous COVID

ACTIVE COMPARATOR

Sinus floor augmentation in the posterior atrophic maxilla with delayed implant placement in patients with negative history of COVID-19 infection.

Procedure: Sinus lift with negative COVID-19 history

Interventions

Sinus lift in patients with positive COVID-19 historyPROCEDURE

Sinus augmentation in the posterior atrophic maxilla in patients with positive COVID-19 history

Sinus lift in patients with previous COVID-19 infection
Sinus lift with negative COVID-19 historyPROCEDURE

Sinus augmentation in the posterior atrophic maxilla in patients with negative COVID-19 history

Sinus lift in patients with negative history of previous COVID

Eligibility Criteria

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

You may qualify if:

  • mm or less residual alveolar bone height
  • Age more than 18 years
  • Highly motivated patients

You may not qualify if:

  • Patients who suffer from any systemic disease
  • sinus pathosis other than sinusitis induced covid 19
  • Patients under any medication that may interfere with the normal bone healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nahla Awadallah

    Lecturer at Faculty of Dentistry, Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of oral and Maxillofacial Surgery

Study Record Dates

First Submitted

July 22, 2023

First Posted

July 25, 2023

Study Start

March 30, 2023

Primary Completion

July 15, 2023

Study Completion

July 20, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

EG(1)