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Evaluation of B+ Surface on Early Loading

Primary Purpose

Jaw, Edentulous, Partially

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Early Loading

Conventional Loading

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient >18 and ≤75 years old
One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).

Exclusion Criteria:

One-stage bone augmentation
Heavy smokers (>10 cigarettes/day)
Uncontrolled type 1 or 2 diabetes (HgA1c>8)
Known auto-immune or inflammatory disease
Severe hematologic disorders, such as hemophilia or leukemia
Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)
Liver or kidney dysfunction/failure
Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy
Long-term history of oral bisphosphonates use (i.e., 10 years or more)
History of intravenous bisphosphonates
Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system
Severe osseous diseases (e.g., Paget disease of bone)
Pregnant women or nursing mothers
Not able or not willing to follow instructions related to the study procedures

Sites / Locations

Facultad de Odontología

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Loading

Conventional Loading

Arm Description

Implant early loading: prosthesis delivery 4 weeks after implant placement

Implant conventional loading: prosthesis delivery 8 weeks after implant placement

Outcomes

Primary Outcome Measures

Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007

Secondary Outcome Measures

Change in marginal bone level around B+-treated implants after conventional or early loading protocol

Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol

Change in the microbiological profile around B+-treated implants after conventional or early loading protocol

Full Information

NCT ID

NCT03059108

First Posted

February 12, 2017

Last Updated

May 20, 2023

Sponsor

Universidad de Granada

1. Study Identification

Unique Protocol Identification Number

NCT03059108

Brief Title

Evaluation of B+ Surface on Early Loading

Official Title

Evaluation of B+ Surface on Early Loading

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 20, 2017 (Actual)

Primary Completion Date

April 14, 2020 (Actual)

Study Completion Date

April 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaw, Edentulous, Partially

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Loading

Arm Type

Experimental

Arm Description

Implant early loading: prosthesis delivery 4 weeks after implant placement

Arm Title

Conventional Loading

Arm Type

Active Comparator

Arm Description

Implant conventional loading: prosthesis delivery 8 weeks after implant placement

Intervention Type

Procedure

Intervention Name(s)

Early Loading

Intervention Description

The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.

Intervention Type

Procedure

Intervention Name(s)

Conventional Loading

Intervention Description

The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.

Primary Outcome Measure Information:

Title

Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in marginal bone level around B+-treated implants after conventional or early loading protocol

Time Frame

0 (Baseline: prosthesis delivery), 3, 6, and 12 months

Title

Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol

Time Frame

-14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months

Title

Change in the microbiological profile around B+-treated implants after conventional or early loading protocol

Time Frame

-14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient >18 and ≤75 years old One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal). Exclusion Criteria: One-stage bone augmentation Heavy smokers (>10 cigarettes/day) Uncontrolled type 1 or 2 diabetes (HgA1c>8) Known auto-immune or inflammatory disease Severe hematologic disorders, such as hemophilia or leukemia Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology) Liver or kidney dysfunction/failure Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy Long-term history of oral bisphosphonates use (i.e., 10 years or more) History of intravenous bisphosphonates Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system Severe osseous diseases (e.g., Paget disease of bone) Pregnant women or nursing mothers Not able or not willing to follow instructions related to the study procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pablo Galindo-Moreno, DDS, PhD

Organizational Affiliation

Universidad de Granada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Facultad de Odontología

City

Granada

ZIP/Postal Code

18071

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

33210771

Citation

Galindo-Moreno P, Gutierrez-Garrido L, Lopez-Chaichio L, Guerra-Lorenzo C, Rodriguez-Alvarez R, Padial-Molina M. Crestal bone changes around early vs. conventionally loaded implants with a multi-phosphonate coated surface: A randomized pilot clinical trial. Clin Oral Implants Res. 2021 Jan;32(1):75-87. doi: 10.1111/clr.13681. Epub 2020 Dec 18.

Results Reference

result

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Evaluation of B+ Surface on Early Loading

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