NCT03281148

Brief Summary

Patients with hopeless teeth in the esthetic area requiring immediate implant restoration will be recruited to the study. Patients will be divided into two groups; a group will receive immediate implants placed using CAD/CAM guides while the other group will receive immediate implants placed by free hand technique. Accuracy of inserted implants will be measured.

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 Nov 2017

Typical duration 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

September 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

September 10, 2017

Last Update Submit

September 12, 2017

Conditions

Immediate Dental Implants

Keywords

immediate implants, accuracy,extraction sockets

Outcome Measures

Primary Outcomes (1)

  • Linear Deviation

    The amount of linear deviation was measured through three parameters; global, lateral and depth deviation. These parameters will be measured at the apical and coronal center in a mesiodistal and buccolingual plane.

    two months postoperative

Study Arms (2)

Computer guided implant insertion group

EXPERIMENTAL

According to the allocation, the experimental group will receive implants immediately placed in extraction sockets using CAD/CAM surgical guides.

Device: Computer guided implant insertion group

Free hand implant insertion group

ACTIVE COMPARATOR

According to the allocation, the control group will receive implants immediately placed in extraction sockets using traditional free hand technique.

Device: Free hand implant insertion group

Interventions

Computer guided implant insertion groupDEVICE

Implants will be immediately inserted in fresh extraction sockets using CAD/CAM guides

Computer guided implant insertion group
Free hand implant insertion groupDEVICE

Implants will be immediately inserted in fresh extraction sockets using free hand technique

Free hand implant insertion group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with hopeless teeth or remaining roots
  • Bucco-lingual bone thickness of 7mm or more (Spray et al., 2000)
  • Bucco-lingual keratinized mucosa of 6mm or more (Spray et al., 2000)
  • Inter-arch space sufficient for prosthetic rehabilitation (7mm or more) (Misch, 2008)
  • Adults more than 18 years old

You may not qualify if:

  • Uncontrolled diabetic patients (HbA1c value ≥ 8.1 percent) (Takeshita et al., 1998)(Javed \& Romanos, 2009)(Garg, 2010)(Retzepi \& Donos, 2010)(B R Chrcanovic et al., 2014)
  • Heavy smokers (More than 10 cigarettes per day) (Nitzan et al., 2005) (Strietzel et al., 2007) (Abt, 2009)(Bruno Ramos Chrcanovic et al., 2015)
  • Severe bruxers (Lobbezoo et al., 2006) (Manfredini et al., 2011)(Lin et al., 2012)(Zhou et al., 2015)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alzoubi, Fawaz, Nima Massoomi, and A. N. (2016). Accuracy Assessment of Immediate and Delayed Implant Placements Using CAD/CAM Surgical Guides. Journal of Oral Implantology ., 42(5), 391-398. http://doi.org/10.1002/smll.)) D'haese, J., Van De Velde, T., Komiyama, A., Hultin, M., & De Bruyn, H. (2012). Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clinical Implant Dentistry and Related Research, 14(3), 321-35. http://doi.org/10.1111/j.1708-8208.2010.00275.x Ortega-martínez, J., Pérez-pascual, T., Mareque-bueno, S., & Hernández-alfaro, F. (2012). Immediate implants following tooth extraction . A systematic review. Medicina Oral Patología Oral Y Cirugia Bucal- Oral Surgery Section, 17(2), e251-61. http://doi.org/10.4317/medoral.17469

    BACKGROUND

Study Officials

  • Maha ElKerdawy, Professor

    Professor at Faculty of Dentistry

    STUDY CHAIR

Central Study Contacts

Doaa Mohammed Ayman, PhD

CONTACT

02001285463772do3aa2@live.com

Doaa Ayman, PhD

CONTACT

02001285463772doaa.auf@dentistry.cu.edu.eg

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
Assistant lecturer at Prosthodontic Department Faculty of Dentistry

Study Record Dates

First Submitted

September 10, 2017

First Posted

September 13, 2017

Study Start

November 1, 2017

Primary Completion

March 1, 2019

Study Completion

September 1, 2019

Last Updated

September 13, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share