NCT04100382

Brief Summary

Laser treated short dental implants will be placed in a posterior atrophic ridge with only 8-10 mm available bone height. Their stability will be measured through a period of 12 weeks. They will be compared to the stability of SLA treated Short dental implants placed in the same situations.

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
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

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

September 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 13, 2019

Last Update Submit

September 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of change in implant stability at base line, 2,4,8, 12 weeks

    measuring implant stability with resonance frequency analysis device using implant stability quotation (ISQ) that measures the stiffness and deflection of implant bone complex.

    3 months

Study Arms (1)

Laser and SLA implants

EXPERIMENTAL

Surgical placement of short implants in maxillary posterior teeth with Laser surface treated and SLA surface treated dental implants

Device: Laser and SLA

Interventions

Patients will be randomized into two groups, control group for SLA implants, and study group will receive the Laser treated implants. Implants will be placed classically in the posterior maxillary region and their stability will be measured by ISQ device at the placement. Measurements will be taken again at 2, 4, 6, 8 , 10 and 12 weeks.

Laser and SLA implants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with Edentulous posterior maxillae with insufficient ridge for placement of standard length dental implant, but allowing placement of short 8mm dental implant.
  • Males and females.

You may not qualify if:

  • 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
  • Patients suffering from immunodeficiency, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
  • Intraoral soft and hard tissue pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 24, 2019

Study Start

September 15, 2019

Primary Completion

September 15, 2020

Study Completion

September 15, 2020

Last Updated

September 24, 2019

Record last verified: 2019-09