Partial-edentulismNCT05583123
One-piece and Two-piece Zirconia Abutments in Single Implant Crowns in Esthetic Region
A study testing restored abutment (OPZAs) and restored abutment (TPZAs) in people with Partial-edentulism, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The goal of this clinical trail is to evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial-edentulism
- What is being tested?
- restored abutment (OPZAs) and restored abutment (TPZAs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 1 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age≥18;
- patients with two missing teeth in esthetic region and plan to be restored with two single implant crowns;
- adjacent to natural teeth;
- absence of oral mucosal disease and oral infection;
- implants with conical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
- patients with the willingness to participate in the present study.
Who cannot join
- heavy smokers (>10 cigarettes/day);
- uncontrolled periodontitis (Full mouth plaque score>20%, full mouth bleeding score>25%, residual pocket depth>5mm);
- with systematic diseases that may affect implant therapy, such as uncontrolled diabetes mellitus (Fasting blood-glucose>7.2mmol/L, Glycosylated hemoglobin >7%), current intake of bisphosphonates (treatment for malignancy), pregnant(or plan to get pregnant), with history of radiation therapy in head and neck region.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
=Shanghai Ninth People's Hospital, China
Shanghai, Shanghao, 200001
Xiaolei Lv, MD, 18817617580, lyuxiaolei01@163.com
About this study
Official title: Evaluation of the One-piece Zirconia Abutments and Two-piece Zirconia Abutments With Titanium Bases for Single Implant Crowns in Esthetic Region: a Randomized Split-mouth Clinical Trial With 1-year Follow-up
The goal of this clinical trail is to evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. The main question it aims to answer is:
whether the mechanical properties of one-piece zirconia abutments are the same as those of two-piece zirconia abutments.
Participants who have two missing teeth in aesthetic region will receive the OPZAs for one restoration and the TPZAs for the other.
Researchers will compare OPZAs group (OG) and TPZAs group (TG) to see the clinical, radiological and immunological outcomes of the two.
Read the detailed description
Objective: To evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region.
Materials and methods: The study is a single center, split-mouth and randomized controlled clinical trial. Eligible sites of patients will be randomly assigned into two groups: OPZAs group (OG) and TPZAs group (TG). Survival rates, mechanical complication rates, bleeding on probing (BOP%), probing depth (PD), modified plaque index (mPI), marginal bone loss (MBL), concentrations of pro-inflammatory cytokines (TNF-α, IL-6) in peri-implant crevicular fluid (PICF), and pink esthetics score/white esthetics score (PES/ WES) will be evaluated.
Discussion: Results of the present study will help to evaluate the clinical, radiological and immunological outcomes of OPZAs and TPZAs with friction-fitted titanium bases in single implant crowns in aesthetic region and provide evidence for the effects of two types abutments on the health of peri-implant soft and hard tissue.
- Conditions
- Partial-edentulism
- Being tested
- restored abutment (OPZAs), restored abutment (TPZAs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restored abutment (OPZAs)Device
The restorations will be restored by the OPZAs
restored abutment (TPZAs)Device
The restorations will be restored with the TPZAs with friction-fitted titanium bases.
| Study group | Role | What they receive |
|---|---|---|
| OPZAs group (OG) | Experimental | one-piece zirconia abutments (OPZAs) Receives: Device: restored abutment (OPZAs) |
| TPZAs group (TG) | Active comparator | two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases Receives: Device: restored abutment (TPZAs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical complications rates
Veneer chipping, abutments or implants fracture, screw loosening or fracture and other mechanical complications will be recorded during the 1-year follow-up.
Measured: 1 year
Secondary outcomes (8)
Survival rates
The survival rate was defined as the percentage of success implants and remained crowns which never been replaced.
Measured: 1 year
Peri-implant conditions-BOP%
peri-implant conditions included bleeding on probing% (BOP%)
Measured: 1 year
Peri-implant conditions-PD
pocket probing depth (PD) in mm
Measured: 1 year
Peri-implant conditions-mPI
modified plaque index (mPI).
Measured: 1 year
Marginal bone loss (MBL)
Peri-apical radiographs with paralleling technique will be performed on the day of final restorations delivery and 1 year later. The implant length is used as calibration reference. The distance between restoration margin and the most coronal level of implant-bone contact will be recorded. The final result calculate as the mean value of mesial and distal sites. The alteration of the distance between baseline and 1-year follow-up is defined as the MBL.
Measured: 1 year
Pro-inflammatory cytokines in peri-implant crevicular fluid (PICF)
We will collect the patients' PICF with the paper strip (PerioPaper Strips; Oraflow Inc., Smithtown, NY, USA) at 1-year follow-up to access differences in pro-inflammatory cytokines (IL-6 and TNF-α) between two groups. Enzyme-linked immunosorbent assay (ELISA) will be used to analyzed PICF and evaluated the concentrations of cytokines. The PICF collection method and cytokines determination referred to Christopher A. Barwacz et al.
Measured: 1 year
PES
In this study, pink aesthetic score (PES) will be applied for the objective esthetic assessment of the final restoration. We will take patients' intraoral photos by the camera (D70, Nikon, Tokyo, Japan) at 1 year follow up. The aesthetic effect will be assessed by two specific dentists independently. They will asked to give scores for variables of PES (Mesial papilla, distal papilla, level of soft-tissue margin, soft-tissue contour, alveolar process and soft-tissue color and texture) and WES (Tooth form, tooth volume/outline, color, surface texture and transparency) with the 0-1-2 scoring system. Final PES/WES is the sum of the two.
Measured: 1 year
WES
In this study, white esthetic score (WES) will be applied for the objective esthetic assessment of the final restoration. We will take patients' intraoral photos by the camera (D70, Nikon, Tokyo, Japan) at 1 year follow up. The aesthetic effect will be assessed by two specific dentists independently. They will asked to give scores for variables of PES (Mesial papilla, distal papilla, level of soft-tissue margin, soft-tissue contour, alveolar process and soft-tissue color and texture) and WES (Tooth form, tooth volume/outline, color, surface texture and transparency) with the 0-1-2 scoring system. Final PES/WES is the sum of the two.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start15 Jan 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Hongchang Lai, Professor, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583123
- Sponsor's protocol ID
- SH9th-20-12
- Status last verified
- Feb 2023
- First submitted
- 6 Mar 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the One-piece Zirconia Abutments and Two-piece Zirconia Abutments With Titanium Bases for Single Implant Crowns in Esthetic Region: a Randomized Split-mouth Clinical Trial With 1-year Follow-up
- ClinicalTrials.gov ID
- NCT05583123
- Acronym / sponsor ID
- SH9th-20-12
- Conditions
- Partial-edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Oct 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 goal of this clinical trail is to evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. The main question it aims to answer is:
whether the mechanical properties of one-piece zirconia abutments are the same as those of two-piece zirconia abutments.
Participants who have two missing teeth in aesthetic region will receive the OPZAs for one restoration and the TPZAs for the other.
Researchers will compare OPZAs group (OG) and TPZAs group (TG) to see the clinical, radiological and immunological outcomes of the two.
Detailed description
Objective: To evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region.
Materials and methods: The study is a single center, split-mouth and randomized controlled clinical trial. Eligible sites of patients will be randomly assigned into two groups: OPZAs group (OG) and TPZAs group (TG). Survival rates, mechanical complication rates, bleeding on probing (BOP%), probing depth (PD), modified plaque index (mPI), marginal bone loss (MBL), concentrations of pro-inflammatory cytokines (TNF-α, IL-6) in peri-implant crevicular fluid (PICF), and pink esthetics score/white esthetics score (PES/ WES) will be evaluated.
Discussion: Results of the present study will help to evaluate the clinical, radiological and immunological outcomes of OPZAs and TPZAs with friction-fitted titanium bases in single implant crowns in aesthetic region and provide evidence for the effects of two types abutments on the health of peri-implant soft and hard tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPZAs group (OG) | Experimental | Device: restored abutment (OPZAs)one-piece zirconia abutments (OPZAs) |
| TPZAs group (TG) | Active comparator | Device: restored abutment (TPZAs)two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age≥18;
- patients with two missing teeth in esthetic region and plan to be restored with two single implant crowns;
- adjacent to natural teeth;
- absence of oral mucosal disease and oral infection;
- implants with conical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
Key exclusion criteria (3 listed)
- heavy smokers (>10 cigarettes/day);
- uncontrolled periodontitis (Full mouth plaque score>20%, full mouth bleeding score>25%, residual pocket depth>5mm);
- with systematic diseases that may affect implant therapy, such as uncontrolled diabetes mellitus (Fasting blood-glucose>7.2mmol/L, Glycosylated hemoglobin >7%), current intake of bisphosphonates (treatment for malignancy), pregnant(or plan to get pregnant), with history of radiation therapy in head and neck region.
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 |
|---|---|---|
| restored abutment (OPZAs)The restorations will be restored by the OPZAs | Device | OPZAs group (OG) |
| restored abutment (TPZAs)The restorations will be restored with the TPZAs with friction-fitted titanium bases. | Device | TPZAs group (TG) |
Primary outcome
Mechanical complications rates
Time frame: 1 year
Veneer chipping, abutments or implants fracture, screw loosening or fracture and other mechanical complications will be recorded during the 1-year follow-up.
8 secondary outcomes
Survival rates
Time frame: 1 year
Peri-implant conditions-BOP%
Time frame: 1 year
Peri-implant conditions-PD
Time frame: 1 year
Peri-implant conditions-mPI
Time frame: 1 year
Marginal bone loss (MBL)
Time frame: 1 year
Pro-inflammatory cytokines in peri-implant crevicular fluid (PICF)
Time frame: 1 year
PES
Time frame: 1 year
WES
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Hongchang Lai, Professor principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restored abutment (OPZAs) and restored abutment (TPZAs) in people with Partial-edentulism, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Lei Lv (86-18817617580, lyuxiaolei01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical complications rates (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.