NCT03220815

Brief Summary

20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)

  • for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
  • In the study group: implant will be inserted in the low speed osteotomy site. • In the control group: implants will be inserted in the conventional prepared osteotomy site.
  • For both groups there is no surgical guide used.
  • The flap will then be copiously irrigated with saline in preparation for closure.
  • The flap will then be closed using interrupted 4/0 resorbable sutures.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

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

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

July 15, 2017

Last Update Submit

July 15, 2017

Conditions

Bone Resorption

Outcome Measures

Primary Outcomes (1)

  • crestal bone loss

    measurement from radiographic analysis using digital periapical x-ray

    [Time Frame: 6 month]

Secondary Outcomes (2)

  • patient morbidity after procedure

    [Time Frame: 1 day]

  • Implant stability value

    [Time Frame: 3 month]

Study Arms (2)

Biologic drilling drilling at low speed

EXPERIMENTAL
Procedure: Drilling at low speed

conventional drilling drilling at high speed

ACTIVE COMPARATOR
Procedure: Conventional drilling at high speed

Interventions

Drilling at low speedPROCEDURE
Biologic drilling drilling at low speed
Conventional drilling at high speedPROCEDURE
conventional drilling drilling at high speed

Eligibility Criteria

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

You may qualify if:

  • Patients restoring missing maxillary teeth with implant placement.
  • Both sexes.
  • Age: 25-45
  • Mesio-distal dimensions: Not less than 6 mm
  • Bone Height: Not less than 12 mm
  • Bucco-lingual dimensions: Not less than 8mm
  • All measures will be assessed using CBCT.

You may not qualify if:

  • Sites needing bone grafting or augmentation.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 15, 2017

First Posted

July 18, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

July 18, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share