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

Not Applicable

Withdrawn

• Conditions: Dental Implants
• Interventions: Device: Dental Implant

• Registration Number: NCT02836964
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-19
• Study Start: 2017-02
• Primary Completion: 2018-02
• Study Completion: 2018-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Loading of Dental Implants after 4 weeks	Dental Implant	A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar. for this group. After 4 weeks definitive crown will be placed.
Loading of Dental Implants after 3 months	Dental Implant	A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar for this group. After 3 months definitive crown will be placed

Primary Outcome Measures

Name	Time	Method
Assessment of marginal bone level changes	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

Trial Locations

Locations (1)

Loma Linda University, Center for Implant Dentistry; 🇺🇸 Loma Linda, California, United States