Trial Outcomes & Findings for PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up (NCT NCT04598776)

Results Overview

Implant without pain, without mobility and in function.

Recruitment status

COMPLETED

Target enrollment

98 participants

Primary outcome timeframe

Baseline to 3 years

Results posted on

2024-12-06

Participant Flow

Participants were included if received a CeraRoot implant between August 27th 2020 and December 4th 2023, provided the inclusion criteria were met.

98 patients with a total of 175 implants met the inclusion criteria.

Unit of analysis: implants

Participant milestones

Participant milestones
Measure	CeraRoot Ceramic Implants patients that received CeraRoot ceramic implants.
Overall Study STARTED	98 175
Overall Study COMPLETED	89 162
Overall Study NOT COMPLETED	9 13

Reasons for withdrawal

Reasons for withdrawal
Measure	CeraRoot Ceramic Implants patients that received CeraRoot ceramic implants.
Overall Study Protocol Violation	5
Overall Study Physician Decision	4

Baseline Characteristics

PMCF Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CeraRoot Implant n=175 implants CeraRoot ceramic dental implant one-piece
Age, Customized Age <21	2 Participants n=98 Participants
Age, Customized 21-40	14 Participants n=98 Participants
Age, Customized 41-60	54 Participants n=98 Participants
Age, Customized 61-80	28 Participants n=98 Participants
Sex: Female, Male Female	57 Participants n=98 Participants
Sex: Female, Male Male	41 Participants n=98 Participants
Region of Enrollment Spain	98 Participants n=98 Participants

PRIMARY outcome

Timeframe: Baseline to 3 years

Implant without pain, without mobility and in function.

Outcome measures

Outcome measures
Measure	CeraRoot Implants n=162 implants CeraRoot ceramic implants (one-piece)
Number of Implants That Survived SUCCESS	157 implants
Number of Implants That Survived FAILURE	5 implants

SECONDARY outcome

Timeframe: Baseline to 7 days

Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected

Outcome measures

Outcome measures
Measure	CeraRoot Implants n=162 implants CeraRoot ceramic implants (one-piece)
Number of Implants With Surgical Complications (SC)	0 implants

SECONDARY outcome

Timeframe: 7 days post operative to delivery of prosthesis

Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected

Outcome measures

Outcome measures
Measure	CeraRoot Implants n=162 implants CeraRoot ceramic implants (one-piece)
Number of Implants With Before Loading Implants Complications (BLIC)	0 implants

SECONDARY outcome

Timeframe: From delivery of prosthesis to two years later.

Population: Patients that received CeraRoot implants and were not excluded from the study.

Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded.

Outcome measures

Outcome measures
Measure	CeraRoot Implants n=162 implants CeraRoot ceramic implants (one-piece)
Number of Implants With After Loading Implants Complications (ALIC) Occlusal premature contact	1 implants
Number of Implants With After Loading Implants Complications (ALIC) Premature Loading	2 implants
Number of Implants With After Loading Implants Complications (ALIC) Aseptic Losening	1 implants
Number of Implants With After Loading Implants Complications (ALIC) Sinus Infection	1 implants

SECONDARY outcome

Timeframe: Baseline to 3 years

Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered.

Outcome measures

Outcome measures
Measure	CeraRoot Implants n=162 implants CeraRoot ceramic implants (one-piece)
Number of Units With Prosthetic Complications (PC)	0 implants

Adverse Events

CeraRoot Implants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Josep Oliva-Ochoa. Director of Clinical Trials

CeraRoot CLINIC

Phone: +34 935950247

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place