NCT01970826

Brief Summary

In patients that require dental implants , does performing the surgery in clean sterile field compared to aseptic field, produces more post-operatory complications, implant morbidity or patient discomfort ?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

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

October 19, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 28, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

October 19, 2013

Last Update Submit

October 22, 2013

Conditions

Endosseous Dental Implant FailureBone Loss

Keywords

aseptic sterilized fieldclean sterilized fielddental implantsSurgery

Outcome Measures

Primary Outcomes (2)

  • Post-Operatory Complications

    Measure the amount of adverse effects in both groups (aseptic vs clean) that happen between time frame baseline to 4 weeks.

    From Implant Placement (Baseline) to 4 weeks after (T1)

  • Osseointegration

    Measure the ability of dental implants to integrate into bone in both groups (aseptic vs clean)

    At 8 weeks (T2) after Baseline

Secondary Outcomes (2)

  • Marginal bone loss

    At Final Restoration placement - Expected Average of 12 Weeks after baseline

  • Patient Satisfaction

    At 2 weeks

Study Arms (6)

Sterilized Clean Full-Mouth

EXPERIMENTAL

The operatory room will be prepared with clean instruments but with no aseptic preparation. Full-mouth dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies. There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product. It will be evaluated the duration of surgery.

Procedure: Sterilized CleanProcedure: Full-Mouth Dental ImplantsProcedure: Duration of Surgery

Sterilized Aseptic Full-Mouth

ACTIVE COMPARATOR

The operatory room will be prepared with sterilized aseptic clean instruments. Full-mouth dental implants placement will be performed and involves meticulous hand washing, use of a sterile field, use of sterile gloves for application of a sterile dressing, and use of sterile instruments and fluid only. Involves the use of only sterile instruments and materials in dressing. There is no contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or products. It will be evaluated the duration of surgery.

Procedure: Sterilized AsepticProcedure: Full-Mouth Dental ImplantsProcedure: Duration of Surgery

Sterilized Clean Single

EXPERIMENTAL

The operatory room will be prepared with clean instruments but with no aseptic preparation. Single dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies. There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or products. It will be evaluated the duration of surgery.

Procedure: Single Dental ImplantsProcedure: Sterilized CleanProcedure: Duration of Surgery

Sterilized Aseptic Single

ACTIVE COMPARATOR

The operatory room will be prepared with clean instruments but with no aseptic preparation. Single dental implants placement will be made, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies. There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product. It will be evaluated the duration of surgery.

Procedure: Single Dental ImplantsProcedure: Sterilized AsepticProcedure: Duration of Surgery

Sterilized Clean - Partial

EXPERIMENTAL

The operatory room will be prepared with clean instruments but with no aseptic preparation. One or more dental implants will be made for partial rehabilitation, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies. There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product. It will be evaluated the duration of surgery.

Procedure: Sterilized CleanProcedure: Partial RehabilitationProcedure: Duration of Surgery

Sterilized Aseptic - Partial

ACTIVE COMPARATOR

The operatory room will be prepared with clean instruments but with no aseptic preparation. One or more dental implants will be made for partial rehabilitation, Clean technique involves meticulous hand-washing, maintaining a clean environment by preparing a clean field, using clean gloves and sterile instruments, and preventing direct contamination of materials and supplies. There is contact between : non-sterile material in any change procedures and contact between sterile instruments or materials and any non-sterile surface or product. It will be evaluated the duration of surgery.

Procedure: Sterilized AsepticProcedure: Partial RehabilitationProcedure: Duration of Surgery

Interventions

Single Dental ImplantsPROCEDURE

place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.

Also known as: Dental Fixtures
Sterilized Aseptic SingleSterilized Clean Single
Sterilized AsepticPROCEDURE

Operatory room will be prepared totally aseptic

Also known as: aseptic operatory room
Sterilized Aseptic - PartialSterilized Aseptic Full-MouthSterilized Aseptic Single
Sterilized CleanPROCEDURE

Operatory room will be prepared clean but not aseptic

Also known as: Clean operatory room
Sterilized Clean - PartialSterilized Clean Full-MouthSterilized Clean Single
Full-Mouth Dental ImplantsPROCEDURE

dental implants for full-mouth implant rehabilitation.

Also known as: Full-mouth rehabilitation, Full mouth implant supported rehabilitation
Sterilized Aseptic Full-MouthSterilized Clean Full-Mouth
Partial RehabilitationPROCEDURE

two or more implants to support partial rehabilitation

Also known as: partial implant-supported rehabilitation
Sterilized Aseptic - PartialSterilized Clean - Partial
Duration of SurgeryPROCEDURE

it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.

Also known as: Time for implant placement
Sterilized Aseptic - PartialSterilized Aseptic Full-MouthSterilized Aseptic SingleSterilized Clean - PartialSterilized Clean Full-MouthSterilized Clean Single

Eligibility Criteria

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

You may qualify if:

  • All surgeries schedule for implant placement

You may not qualify if:

  • Surgeries not made with local anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lisbon, School of Dentistry

Lisbon, Lisbon District, 1600, Portugal

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Dental ImplantsTime

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and AgriculturePhysical Phenomena

Study Officials

  • Andre Chen, Msc

    University of Lisbon, College of Dentistry

    PRINCIPAL INVESTIGATOR

  • João Caramês, Phd

    University of Lisbon, College of Dentistry

    STUDY DIRECTOR

  • João Canta, Msc

    University of Lisbon, School of Dentistry

    STUDY CHAIR

  • Helena Francisco, Msc

    University of Lisbon, College of Dentistry

    STUDY CHAIR

Central Study Contacts

André Chen, Msc

CONTACT

00351919774343tsouchen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

October 19, 2013

First Posted

October 28, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

October 28, 2013

Record last verified: 2013-10

Locations

PT(1)