Edentulous PatientsNCT05307029

Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws

An observational study of Edentulous Patients, run by University of Roma La Sapienza.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study involved 28 edentulous patients (20 female/8 males; average age of 67.75± 8.627 years) rehabilitated with 33 prostheses (17 all-on-4/16 all-on-6) supported by 164 implants. Read more about this study

Who is it for?: Any age
Conditions the study is for: Edentulous Patients
What is being tested?: rehabilitation with fixed full-arch prosthesis
Type of treatment: Surgery or procedure
How many people: 28 participants
Where: No sites listed yet
Study dates: 20 Feb 2009to 26 Feb 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: In this retrospective cohort study, participants were recruited from edentulous patients rehabilitated with fixed full-arch prosthesis on 4 or 6 implants according to the Nobelguide® protocol between Jun 2009 and December 2019 at the Oral Surgery Unit, Policlinico Umberto I, "Sapienza" University of Rome, Italy. No randomization was applied.

Who may be able to join

Mandibles or maxillae edentulous or with hopeless teeth;
Patient's request of fixed implant restorations
Patients in general good health (ASA-1/ASA-2)

Who cannot join

Compromised systemic conditions;
Head/neck irradiation or chemotherapy within 2 years;
Bisphosphonate therapy;
Metabolic bone diseases;
Insufficient bone volume;
Mouth opening less than 50 mm inadequate to place surgical instrumentations.
History of periodontitis or smoking habit were not considered exclusion criteria.

About this study

Official title: Immediate Fixed Full-arch Rehabilitation of Edentulous Jaws on 4 or 6 Implants According to the Nobelguide® Protocol: a Retrospective Study on Clinical and Radiographic Outcomes up to 10 Years of Follow-up.

The study involved 28 edentulous patients (20 female/8 males; average age of 67.75± 8.627 years) rehabilitated with 33 prostheses (17 all-on-4/16 all-on-6) supported by 164 implants.

Read the detailed description

Clinical and radiographic outcomes were implants survival, prostheses success/survival, implant marginal bone loss, incidence of biological and prosthetic complications.

Conditions: Edentulous Patients
Being tested: rehabilitation with fixed full-arch prosthesis
Keywords: full- arch implant prosthesis, flapless implant surgery, immediate Dental Implant Loading, Surgery, Computer-Assisted, Dental Implants, template-guided surgery, all on four, all on six, ; tilted implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rehabilitation with fixed full-arch prosthesisProcedure or surgery

Study groups in NCT05307029
Study group	Role	What they receive
Group A edentulous patients		edentulous patients rehabilitated with fixed full-arch prosthesis on 4 implants Receives: Procedure: rehabilitation with fixed full-arch prosthesis
Group B edentulous patients		edentulous patients rehabilitated with fixed full-arch prosthesis on 6 implants Receives: Procedure: rehabilitation with fixed full-arch prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

Implant marginal bone loss (MBL)
difference in marginal bone level from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up measured in millimeters/years on periapical radiographs. Periapical radiographs of each implant were taken every year using the parallel long-cone technique and a standardized film holder (Rinn Centratore XCP Evolution 2003, Dentsply, Rome, Italy).
Measured: from the functional loading time with the provisional prosthesis (baseline) T0 to the end of the follow-up, assessed up to 10 years and measured in millimeters on periapical radiographs taken every year using the parallel long-cone technique.
Prosthetic complications
included detachment/incisal and occlusal wear/fracture/chipping/replacing of denture teeth, fracture of implant, prosthesis or framework, loosening/fracture of abutment or occlusal screw, loosening/fracture of the prosthetic screw
Measured: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.
Biologic complications
inflammation / infection under fixed prosthesis, soft tissue hypertrophy / hyperplasia, soft tissue recession / dehiscence, peri-implant mucositis, peri-implantitis.
Modified plaque index (mPI), modified gingival index (mGI), bleeding on probing (BoP), and probing depth (PD). mPI, mGI, BoP, and PD measurements were performed at 6 aspects per implant. mPI was scored as: 0 = no detection of plaque; 1 = plaque only recognized by running a probe across the smooth marginal surface of the implant; 2 = plaque can be seen by the naked eye; 3 = abundance of soft matter. mGI was scored as: 0 = no bleeding when a periodontal probe is passed along the mucosal margin adjacent to the implant; 1 = isolated bleeding spots visible; 2 = blood forms a confluent red line on mucosal margin; 3 = heavy or profuse bleeding. BoP was scored as 0 = absence; 1 = presence; PD was measured in mm.
Measured: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 200926 Feb 2019

First posted1 Apr 2022
Study start20 Feb 2009
Primary completion10 Feb 2014
Study completion26 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Edentulous PatientsStudies of the same condition, open and under way.
More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05307029
Sponsor's protocol ID: 0000505/26.04.2021
Status last verified: Mar 2022
First submitted: 17 Jan 2022
Last updated: 1 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Recruiting
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
Edentulous Complete Denture Wearers
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
Not yet recruiting
Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients

All Edentulous Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate Fixed Full-arch Rehabilitation of Edentulous Jaws on 4 or 6 Implants According to the Nobelguide® Protocol: a Retrospective Study on Clinical and Radiographic Outcomes up to 10 Years of Follow-up.
ClinicalTrials.gov ID: NCT05307029
Acronym / sponsor ID: 0000505/26.04.2021
Conditions: Edentulous Patients
Keywords: full- arch implant prosthesis, flapless implant surgery, immediate Dental Implant Loading, Surgery, Computer-Assisted, Dental Implants, template-guided surgery, all on four
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of Roma La SapienzaUniversity, hospital or other
Study start: 20 Feb 2009 (actual)
Primary completion: 10 Feb 2014 (actual)
Study completion: 26 Feb 2019 (actual)
First posted: 1 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study involved 28 edentulous patients (20 female/8 males; average age of 67.75± 8.627 years) rehabilitated with 33 prostheses (17 all-on-4/16 all-on-6) supported by 164 implants.

Detailed description

Clinical and radiographic outcomes were implants survival, prostheses success/survival, implant marginal bone loss, incidence of biological and prosthetic complications.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Group A edentulous patients	–	Procedure: rehabilitation with fixed full-arch prosthesisedentulous patients rehabilitated with fixed full-arch prosthesis on 4 implants
Group B edentulous patients	–	Procedure: rehabilitation with fixed full-arch prosthesisedentulous patients rehabilitated with fixed full-arch prosthesis on 6 implants

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: In this retrospective cohort study, participants were recruited from edentulous patients rehabilitated with fixed full-arch prosthesis on 4 or 6 implants according to the Nobelguide® protocol between Jun 2009 and December 2019 at the Oral Surgery Unit, Policlinico Umberto I, "Sapienza" University of Rome, Italy. No randomization was applied.

Key inclusion criteria (3 listed)

Mandibles or maxillae edentulous or with hopeless teeth;
Patient's request of fixed implant restorations
Patients in general good health (ASA-1/ASA-2)

Key exclusion criteria (7 listed)

Compromised systemic conditions;
Head/neck irradiation or chemotherapy within 2 years;
Bisphosphonate therapy;
Metabolic bone diseases;
Insufficient bone volume;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rehabilitation with fixed full-arch prosthesis	Procedure or surgery	Group A edentulous patients, Group B edentulous patients

Primary outcome

Implant marginal bone loss (MBL)
Time frame: from the functional loading time with the provisional prosthesis (baseline) T0 to the end of the follow-up, assessed up to 10 years and measured in millimeters on periapical radiographs taken every year using the parallel long-cone technique.
difference in marginal bone level from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up measured in millimeters/years on periapical radiographs. Periapical radiographs of each implant were taken every year using the parallel long-cone technique and a standardized film holder (Rinn Centratore XCP Evolution 2003, Dentsply, Rome, Italy).
Prosthetic complications
Time frame: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.
included detachment/incisal and occlusal wear/fracture/chipping/replacing of denture teeth, fracture of implant, prosthesis or framework, loosening/fracture of abutment or occlusal screw, loosening/fracture of the prosthetic screw
Biologic complications
Time frame: Every 6 months from the functional loading time with the provisional prosthesis (baseline) to the end of the follow-up, assessed up to 10 years.
inflammation / infection under fixed prosthesis, soft tissue hypertrophy / hyperplasia, soft tissue recession / dehiscence, peri-implant mucositis, peri-implantitis. Modified plaque index (mPI), modified gingival index (mGI), bleeding on probing (BoP), and probing depth (PD). mPI, mGI, BoP, and PD measurements were performed at 6 aspects per implant. mPI was scored as: 0 = no detection of plaque; 1 = plaque only recognized by running a probe across the smooth marginal surface of the implant; 2 = plaque can be seen by the naked eye; 3 = abundance of soft matter. mGI was scored as: 0 = no bleeding when a periodontal probe is passed along the mucosal margin adjacent to the implant; 1 = isolated bleeding spots visible; 2 = blood forms a confluent red line on mucosal margin; 3 = heavy or profuse bleeding. BoP was scored as 0 = absence; 1 = presence; PD was measured in mm.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.

Related trials for Edentulous Patients

Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Recruiting
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
Edentulous Complete Denture Wearers
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
Not yet recruiting
Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria Paola Cristalli, DDS study director

Sapienza University of Roma

Questions about this trial

What is this clinical trial studying?

An observational study of Edentulous Patients, run by University of Roma La Sapienza.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant marginal bone loss (MBL) (time frame: from the functional loading time with the provisional prosthesis (baseline) T0 to the end of the follow-up, assessed up to 10 years and measured in millimeters on periapical radiographs taken every year using the parallel long-cone technique.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05307029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.