NCT03743545

Brief Summary

ASSESSMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONAL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS

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
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

November 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 4, 2018

Last Update Submit

November 15, 2018

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (1)

  • Measurement of heat generation from low speed hand piece drills drilling by thermocouple technology

    Measurement of 3 different depths(mms). Data analyzed with a three-way analysis of variance by Newman-Keulsmultiple comparison procedure. The significance level was set to a p-value of 0.05.

    6 months

Secondary Outcomes (1)

  • stability-osstell device to assess the primary stability of placed dental implant

    6 months

Study Arms (2)

conventional drilling with irrigation

ACTIVE COMPARATOR
Other: low speed drilling without irrigation

low speed without irrigation

EXPERIMENTAL
Other: low speed drilling without irrigation

Interventions

low speed drilling without irrigationOTHER

comparing between conventional implant placement drilling speed with irrigation and experimental arm (low speed without irrigation)

conventional drilling with irrigationlow speed without irrigation

Eligibility Criteria

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

You may not qualify if:

  • presence of pathological lesions heavy smokers more than 20 cigarettes per day patients with systemic disease that may affect normal healing Patients with no enough bone in posterior mandible for implant placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Therapeutic Irrigation

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: healthy posterior mandible
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

November 4, 2018

First Posted

November 16, 2018

Study Start

December 1, 2018

Primary Completion

March 1, 2019

Study Completion

April 2, 2019

Last Updated

November 19, 2018

Record last verified: 2018-11