NCT03230500

Brief Summary

Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. patient satisfaction will be evaluated as primary outcome and early implant failure was evaluated as secondary outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

July 24, 2017

Last Update Submit

July 20, 2020

Conditions

Dental Implants

Keywords

computer guidedimmediate implantpatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)

    0-6 months

Secondary Outcomes (1)

  • Early implant failure

    0-6 months

Study Arms (2)

Computer guided immediate implant placement

EXPERIMENTAL

For the test group, the computer aided surgical guide will be used for implant drilling and placement.

Procedure: Computer guided implant placement

Free hand immediate implant placement

ACTIVE COMPARATOR

For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls.

Procedure: Computer guided implant placement

Interventions

Computer guided implant placementPROCEDURE

Implant will be placed immediately using computer aided surgical guide

Computer guided immediate implant placementFree hand immediate implant placement

Eligibility Criteria

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

You may qualify if:

  • Patients with teeth or remaining roots in the esthetic zone and indicated for extraction and replacement with immediate implant.
  • Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2 mm). This will be confirmed by cone beam computer tomography (CBCT) scan.
  • Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this will be confirmed on the study cast.
  • Presence of adjacent teeth to the tooth or remaining root to be extracted.

You may not qualify if:

  • Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g. clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root that will be extracted.
  • Severe overeruption of the opposing teeth to avoid premature contact with the temporary crown during the healing period.
  • Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy, radiotherapy. Osteonecrosis…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Safaa hussein

Cairo, 0000, Egypt

Location

Related Publications (3)

  • Schropp L, Isidor F, Kostopoulos L, Wenzel A. Patient experience of, and satisfaction with, delayed-immediate vs. delayed single-tooth implant placement. Clin Oral Implants Res. 2004 Aug;15(4):498-503. doi: 10.1111/j.1600-0501.2004.01033.x.

    PMID: 15248886BACKGROUND

  • Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.

    PMID: 18332753BACKGROUND

  • Sabir M, Alam MN. Survival of Implants in Immediate Extraction Sockets of Anterior Teeth: Early Clinical Results. J Clin Diagn Res. 2015 Jun;9(6):ZC58-61. doi: 10.7860/JCDR/2015/13631.6123. Epub 2015 Jun 1.

    PMID: 26266220RESULT

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the trial only the outcome assessor will be masked from the intervention or control group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 26, 2017

Study Start

February 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 21, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)