NCT03598049

Brief Summary

comparing the drilling technique of using densah burs osseo densification drills in posterior maxilla with the normal surgical kit drilling

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Status
unknown

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

June 29, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

June 29, 2018

Last Update Submit

August 13, 2018

Conditions

Keywords

ImplantsStabilityBone lossSuccess

Outcome Measures

Primary Outcomes (1)

  • implant stability

    measurement of implant stability using the ostell

    at the time of surgery

Secondary Outcomes (1)

  • Marginal bone loss

    3 month

Other Outcomes (1)

  • patient satisfaction

    3 month

Study Arms (2)

densah burs drilling group

EXPERIMENTAL

implant osteotomy site drilling using the densah burs osseo densification drills

Device: densah burs osseo densification drills

surgical burs drilling group

ACTIVE COMPARATOR

implant osteotomy site drilling using conventional surgical burs drilling

Device: conventional surgical burs drilling

Interventions

osseo densification of the alveolar bone in maxillary posterior ridge during implant placement

densah burs drilling group

conventional implant osteotomy site drilling with implant surgical kit

surgical burs drilling group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤3.5 width implants.
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placement

You may not qualify if:

  • Sinus pathology.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
  • Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Amira khaled, Masters

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 26, 2018

Study Start

September 1, 2018

Primary Completion

May 1, 2019

Study Completion

July 1, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08