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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836964
• Other study ID #: 5160039
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: June 14, 2017
• Start date: February 1, 2017
• Est. completion date: March 2018

Study information

• Verified date: June 2017
• Source: Loma Linda University
• Contact: Bader s albader, DDS
• Phone: 9095584983
• Email: balbader[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the clinical success, stability, radiographic bone level changes and peri-implants soft tissue parameter of the SLActive surface implant supporting single crowns restorations in early loading in the mandibular first molar region.

Description:

The human clinical trial will be designed as a longitudinal prospective study. A total of 24 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar. 12 for the control group and for the 12 test group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 35Ncm

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• Dental Implant
Dental implant

Locations

Country	Name	City	State
United States	Loma Linda Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	marginal bone level changes by using periodical radiography.	Standardized radiographs using customized jig and long cone paralleling technique, using Rinn Film holders (Dentsply, Germany) for assessment of marginal bone level (MBL) will be made at the time of implant placement, as well as at 3 and 6 months 3. Changes in interproximal crestal bone levels will be measured and recorded using NIH Image Program Software(http:/rsb.info.nih.gov/nih-image)	assessment of marginal bone level (MBL) will be made at the time of implant placement and after 6 months