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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Dental Implants
• Intervention / Treatment: Device: Crown placement

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.

• Study Type: Observational
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University, Center for Implant Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Dental patients who are seen at the LLU Department of Implant Dentistry

Description

Inclusion Criteria:

1. Patients aged 18 years or older.
2. Willingness to comply with all study requirements.
3. Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
4. Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
5. Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
6. Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
7. 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:

1. Pregnant or lactating females.
2. Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
3. History of irradiation in the head and neck area.
4. Smoking.
5. Untreated periodontitis.
6. Alcohol or drug abuse.
7. History of Intravenous Bisphosphonate.
8. Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
9. The use of regenerative procedures in conjunction with implant placement.
10. Presence of residual roots at the implant recipient site.
11. Stomatological diseases.
12. Clinical signs of bruxism.
13. Initial stability at least 30Ncm

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A Early Loading; Crown placement will occur at 4 weeks post implant	Device: Crown placement; Dental implant
Group B Conventional Loading; Crown placement will occur at 3 months post implant	Device: Crown placement; Dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of marginal bone level changes	Standardized intraoral radiograph will be used to measure the distance between the implant platform and the marginal bone	Change between Implant Placement Visit and Final evaluation Visit at 6 months post dental implant

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Aladdin Alardah, DDS, MS, Associate Professor

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2017
• Primary Completion (Estimated): February 1, 2018
• Study Completion (Estimated): September 1, 2018

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimated): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 5160039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No