Early Loading of Dental Implants: A Prospective Study in... | NCT02836964

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

NCT02836964

Sponsor

Loma Linda University

Status

Withdrawn

Last Update Posted

Oct 18, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Dental Implants

Interventions

Crown placement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The protocol was completely changed by the resident's guidance committee and the protocol associated with this IRB approval number was never enacted.

Expanded Access Info

Start Date

Feb 2017Estimated

Primary Completion Date

Feb 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Jul 15, 2016

First Posted Date

Jul 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2024

Last Update Posted Date

Oct 18, 2024Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Crown placement	Device	Dental implant	Group A Early Loading Group B Conventional Loading

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%).

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample