NCT04877145

Brief Summary

dental implants are usually placed by sequential set of drills which could increase the time of the surgery and could raise the temperature of the osteotomy preparation so a new drill was designed to place the implants fast and easy way

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 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

February 12, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

4 years

First QC Date

May 1, 2021

Last Update Submit

May 5, 2021

Conditions

Keywords

implants

Outcome Measures

Primary Outcomes (1)

  • osseointegration of the dental implants

    healing and union of the dental implants with the surrounding bone measured by torque wrench exceeds 30 N/CM

    6 months

Secondary Outcomes (2)

  • mobility

    6 months

  • bone loss

    6 months , 1 ,2 and 3 years after function

Study Arms (2)

single drill

EXPERIMENTAL

one drill to place the implants 3.25mm diameter stainless steel drill was used.

Other: drill

sequential drills

ACTIVE COMPARATOR

For the control group, four drills (2.2mm, 2.75mm, 3.25mm and 4mm diameter),

Other: drill

Interventions

drillOTHER

single 3.25 mm stainless steel drill

sequential drillssingle drill

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • implant recipient sites free from any pathological conditions.
  • Patients who were cooperative, motivated and hygiene conscious were selected.
  • non smoker patients

You may not qualify if:

  • Patients unable to undergo minor oral surgical procedures
  • patients with a history of drug abuse or catabolic drugs were not included.
  • Patients with a history of psychiatric disorder and those with unrealistic expectations about the aesthetic outcome of implant therapy were also excluded.
  • Patients with insufficient vertical inter-arch space, on centric occlusion, to accommodate the available restorative components .
  • Uncontrolled diabetic patients
  • Patient who had any systemic condition that may contraindicate implant therapy (impaired wound healing - bleeding disorders
  • patients who had any habits that might jeopardise the osseointegration process, such as heavy smoking and alcoholism.
  • Patients with para-functional habits that produce overload on the implant, such as bruxism and clenching were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111111, Egypt

Location

Related Publications (4)

  • La Du BN. The human serum paraoxonase/arylesterase polymorphism. Am J Hum Genet. 1988 Sep;43(3):227-9. No abstract available.

    PMID: 2843045BACKGROUND
  • Bacci C, Lucchiari N, Frigo AC, Stecco C, Zanette G, Dotto V, Sivolella S. Temperatures generated during implant site preparation with conventional drilling versus single-drill method: an ex-vivo human mandible study. Minerva Stomatol. 2019 Dec;68(6):277-284. doi: 10.23736/S0026-4970.19.04142-6.

    PMID: 32052615BACKGROUND
  • Abboud M, Delgado-Ruiz RA, Kucine A, Rugova S, Balanta J, Calvo-Guirado JL. Multistepped Drill Design for Single-Stage Implant Site Preparation: Experimental Study in Type 2 Bone. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e472-85. doi: 10.1111/cid.12273. Epub 2014 Sep 29.

    PMID: 25263993BACKGROUND
  • Lucchiari N, Frigo AC, Stellini E, Coppe M, Berengo M, Bacci C. In Vitro Assessment with the Infrared Thermometer of Temperature Differences Generated During Implant Site Preparation: The Traditional Technique Versus the Single-Drill Technique. Clin Implant Dent Relat Res. 2016 Feb;18(1):182-91. doi: 10.1111/cid.12246. Epub 2014 Jul 17.

    PMID: 25040939BACKGROUND

MeSH Terms

Interventions

Plyometric Exercise

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • amr ah zahran, phd

    professor of periodontology

    STUDY DIRECTOR

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
lecturer of periodontology and oral implantology - faculty of dentistry , Assiut University - Egypt

Study Record Dates

First Submitted

May 1, 2021

First Posted

May 7, 2021

Study Start

February 12, 2017

Primary Completion

February 8, 2021

Study Completion

April 20, 2021

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

after using the single drill compared with the sequential drill all the implants checked for osseointegration , mobility and bone loss after function

Locations