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Clinical Trials/NCT02836964
NCT02836964
Withdrawn
Not Applicable

Early Loading of Dental Implants: A Prospective Study in the Mandibular First

Loma Linda University1 site in 1 country24 target enrollmentFebruary 2017
ConditionsDental Implants

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implants
Sponsor
Loma Linda University
Enrollment
24
Locations
1
Primary Endpoint
Assessment of marginal bone level changes
Status
Withdrawn
Last Updated
last year

Overview

Brief Summary

This study will compare tissue healing outcome between early dental implant loading at 4 weeks and conventional dental implant loading at 3 months.

Detailed Description

Both loading times are standard of care procedures. The rationale behind early loading is to reduce waiting time so dental implants can be utilized sooner.

Registry
clinicaltrials.gov
Start Date
February 2017
End Date
September 2018
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients aged 18 years or older.
  • Willingness to comply with all study requirements.
  • Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
  • Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
  • Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
  • Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
  • Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo \& Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).

Exclusion Criteria

  • Pregnant or lactating females.
  • Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
  • History of irradiation in the head and neck area.
  • Untreated periodontitis.
  • Alcohol or drug abuse.
  • History of Intravenous Bisphosphonate.
  • Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
  • The use of regenerative procedures in conjunction with implant placement.
  • Presence of residual roots at the implant recipient site.
  • Stomatological diseases.

Outcomes

Primary Outcomes

Assessment of marginal bone level changes

Time Frame: Change between Implant Placement Visit and Final evaluation Visit at 6 months post dental implant

Standardized intraoral radiograph will be used to measure the distance between the implant platform and the marginal bone

Study Sites (1)

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