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

NCT ID: NCT02836964

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-28

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Dental Implants

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A Early Loading

Crown placement will occur at 4 weeks post implant

Crown placement

Intervention Type DEVICE

Dental implant

Group B Conventional Loading

Crown placement will occur at 3 months post implant

Crown placement

Intervention Type DEVICE

Dental implant

Interventions

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Crown placement

Dental implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aladdin Alardah, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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Loma Linda University, Center for Implant Dentistry

Loma Linda, California, United States

Site Status

Countries

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United States

Other Identifiers

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5160039

Identifier Type: -

Identifier Source: org_study_id

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