Comparing two different loading times for dental implants

Not Applicable

Completed

• Conditions: Dental implantation in partially edentulous patients; Oral Health

• Registration Number: ISRCTN10120701
• Lead Sponsor: Clinica Merli

Brief Summary

1. 2008 1-year follow-up results in https://www.ncbi.nlm.nih.gov/pubmed/20467623 2. 2012 3-year follow-up results in https://www.ncbi.nlm.nih.gov/pubmed/22118014

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-05
• Study Start: 2019-04-08
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged 18 years or over
2. Partially dentate and requiring dental implants
3. Implant site allows for the placement of at least one 9.5 mm long implant
4. Bone thickness at the implant site at least 5.5 mm
5. For patients with multiple areas to be restored, the operator was free at the screening visit to select one area to be included in the trial. In this area, multiple neighboring implants could be placed.

Exclusion Criteria

1. General contraindications to implant surgery
2. Patients irradiated in the head and neck area within a year prior to surgery
3. Patients with poor oral hygiene (full-mouth plaque score =30) and lack of motivation
4. Uncontrolled diabetes (diabetes that is not being treated at all, or is not being adequately treated)
5. Pregnant or lactating
6. Substance abusers
7. Psychiatric problems
8. Lack of opposing occluding dentition in the area intended for implant placement
9. Severe bruxism or clenching
10. Active infection or severe inflammation in the area intended for implant placement
11. Presence of =4 mm of keratinized mucosa and/or the need for bone augmentation procedures, with the exception of post-extractive sites treated with Bio-Oss® granules

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant failure (the presence of any mobility of the implant and/or any situation dictating implant removal) after 10 years

Secondary Outcome Measures

Name	Time	Method
<br> 1. Biological or prosthetic complications defined as unexpected deviations from the normal treatment outcome: examples of biological complications are hemorrhaging during and after implant placement and/or peri-implantitis. Prosthetic complications included fracture of the implant or fracture of the prosthesis.<br> 2. Patient's aesthetic and functional satisfaction were assessed by asking the patient for satisfaction on a scale from 0 to 10 where 0 meant completely dissatisfied and 10 meant completely satisfied<br> 3. Peri-implant marginal bone level assessed using periapical intra-oral radiographs taken with the parallel technique at 10 years of follow-up<br>