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

NCT02836964 | Withdrawn

• 1 other identifier: 5160039
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A Early Loading

Crown placement will occur at 4 weeks post implant

Device: Crown placement

Group B Conventional Loading

Crown placement will occur at 3 months post implant

Device: Crown placement

Interventions

Crown placement DEVICE

Dental implant

Group A Early Loading; Group B Conventional Loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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%).

You may not qualify if:

• Pregnant or lactating females.
• Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
• History of irradiation in the head and neck area.
• Smoking.
• 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.
• Clinical signs of bruxism.
• Initial stability at least 30Ncm

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University, Center for Implant Dentistry

Loma Linda, California, 92350, United States

Location

Study Officials

• Aladdin Alardah, DDS, MS

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 19, 2016
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)