Angulated Screw-retainedNCT04539912
Clinical Efficacy of Angulated Screw-retained and Cemented Single Implant Crowns in Esthetic Region
A study testing angulated screw retained crown and cemented crown in people with Angulated Screw-retained and Esthetics, run by Junyu Shi at 1 site in China.
Trial summary
Objective: To compare the clinical efficacy of angulated screw-retained and cemented single implant crowns(SIC) in esthetic region. Methods/Design: The study was a prospective, single center, randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angulated Screw-retained, Esthetics
- What is being tested?
- angulated screw retained crown and cemented crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) age≥18;
- 2) Single dental implant in the esthetic region;
- 3) adjacent to natural teeth;
- 4) absence of oral mucosal disease and oral infection;
- 5)implants withconical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
- 6)patients with the willingness of all-ceramic permanent restorations.
Who cannot join
- 1)Multiple implants in the esthetic region, or the restoration is a bridge;
- 2)Heavy smokers (>10 cigarettes/day);
- 3) the angle between implant axis and restoration axis>25°;
- 4) uncontrolled periodontitis;
- 5) 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;
- 6) Unwilling to participate in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Short-term Clinical Efficacy of Angulated Screw-retained and Cemented Single Implant Crowns in Esthetic Region: A Randomized Controlled Clinical Trial
Objective: To compare the clinical efficacy of angulated screw-retained and cemented single implant crowns(SIC) in esthetic region.
Methods/Design: The study was a prospective, single center, randomized controlled clinical trial. Patients with the needs of single tooth restoration in esthetics region were recruited from Oct. 2018 to Aug. 2019. Sixty patients were enrolled in the present study and they were randomly assigned into two groups: angulated screw-retained group(AG, 30 patients) and cemented group (CG,30 patients). Clinical and radiological evaluations were performed on the day of final crowns delivery and 12 months later. Implant survival rate, marginal bone loss(MBL), pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)(TNF-α, IL-6), mechanical complications, peri-implant conditions(mPI, PD, BOP%), pink esthetics score/white esthetics score (PES/ WES) and patients satisfaction were assessed.
- Conditions
- Angulated Screw-retained, Esthetics
- Being tested
- angulated screw retained crown, cemented crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angulated screw retained crownDevice
ASC abutment was used in AG;
cemented crownDevice
prefabricated Ti abutment was used in CG
| Study group | Role | What they receive |
|---|---|---|
| angulated screw-retained group(AG) | Experimental | Not described Receives: Device: angulated screw retained crown |
| cemented group (CG) | Active comparator | Not described Receives: Device: cemented crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Peri-apical radiographs with paralleling technique wereperformed on the day offinal restorations delivery and 1-year visit. Implant length was used as calibration reference. The distance between restoration margin and the most coronal level of implant-bone contactwas recorded. Final result was calculated as themean value of the mesial and distal sites
Measured: 1year
Secondary outcomes (8)
Survival rate.
Survival rates were defined as the percentage of success implants and remained crowns which never been replaced
Measured: 1 year
Pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)
we collected the patients' PICF with the paper strip (PerioPaper Strips; Oraflow Inc., Smithtown, NY, USA) at 1year follow-up to access differences in pro-inflammatory cytokines (IL-6 and TNF-α) between two groups.
Measured: 1 year
Mechanical complications
Abutments or implants fracture and screw loosening or fracture
Measured: 1 year
pocket probing depth(PD)
The depth of 6 sites（mesial, middle and distal of buccal/lingual ） was measured and the average value was calculated.
Measured: 1 year
PES/WES
specific dentists were 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 2-1-0 scoring system. Final PES/WES was the sum the two. Total scores were defined as perfect rate (PES/WES≥22), acceptable rate (22>PES/WES≥15) and unfavorable rate (PES/WES<15).
Measured: 1 year
Patient's satisfaction
patient's satisfaction(PS) with aesthetics, function and comfort of the restoration at 1-year visit. 0 score was extremely dissatisfied and 10 score was extremely satisfied. We also defined the final scores as perfect rate(PS≥9), acceptable rate(9>PS≥6) and unfavorable rate (PS<6).
Measured: 1 year
bleeding on probing% (BOP%)
The BOP of 6 sites（mesial, middle and distal of buccal/lingual ） was probed and the percentage of BOP(+) was calculated.
Measured: 1 year
modified plaque index (mPI)
Score 0; No detection of plaque Score 1: Plaque only recognized by running a probe across the smooth marginal surface of the implant. Implants covered by titanium spray in this area always score 1.
Score 2: Plaque can be seen by the naked eye. Score 3: Abundance of soft matter.
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 posted7 Sep 2020
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angulated Screw-retainedStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junyu Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539912
- Sponsor's protocol ID
- sh9th-20-09
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Short-term Clinical Efficacy of Angulated Screw-retained and Cemented Single Implant Crowns in Esthetic Region: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04539912
- Acronym / sponsor ID
- sh9th-20-09
- Conditions
- Angulated Screw-retained, Esthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Junyu ShiUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 7 Sep 2020 (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.
Objective: To compare the clinical efficacy of angulated screw-retained and cemented single implant crowns(SIC) in esthetic region.
Methods/Design: The study was a prospective, single center, randomized controlled clinical trial. Patients with the needs of single tooth restoration in esthetics region were recruited from Oct. 2018 to Aug. 2019. Sixty patients were enrolled in the present study and they were randomly assigned into two groups: angulated screw-retained group(AG, 30 patients) and cemented group (CG,30 patients). Clinical and radiological evaluations were performed on the day of final crowns delivery and 12 months later. Implant survival rate, marginal bone loss(MBL), pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)(TNF-α, IL-6), mechanical complications, peri-implant conditions(mPI, PD, BOP%), pink esthetics score/white esthetics score (PES/ WES) and patients satisfaction were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angulated screw-retained group(AG) | Experimental | Device: angulated screw retained crown |
| cemented group (CG) | Active comparator | Device: cemented crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1) age≥18;
- 2) Single dental implant in the esthetic region;
- 3) adjacent to natural teeth;
- 4) absence of oral mucosal disease and oral infection;
- 5)implants withconical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
Key exclusion criteria (6 listed)
- 1)Multiple implants in the esthetic region, or the restoration is a bridge;
- 2)Heavy smokers (>10 cigarettes/day);
- 3) the angle between implant axis and restoration axis>25°;
- 4) uncontrolled periodontitis;
- 5) 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 |
|---|---|---|
| angulated screw retained crownASC abutment was used in AG; | Device | angulated screw-retained group(AG) |
| cemented crownprefabricated Ti abutment was used in CG | Device | cemented group (CG) |
Primary outcome
Marginal bone loss
Time frame: 1year
Peri-apical radiographs with paralleling technique wereperformed on the day offinal restorations delivery and 1-year visit. Implant length was used as calibration reference. The distance between restoration margin and the most coronal level of implant-bone contactwas recorded. Final result was calculated as themean value of the mesial and distal sites
8 secondary outcomes
Survival rate.
Time frame: 1 year
Pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)
Time frame: 1 year
Mechanical complications
Time frame: 1 year
pocket probing depth(PD)
Time frame: 1 year
PES/WES
Time frame: 1 year
Patient's satisfaction
Time frame: 1 year
bleeding on probing% (BOP%)
Time frame: 1 year
modified plaque index (mPI)
Time frame: 1 year
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 7 Sep 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angulated screw retained crown and cemented crown in people with Angulated Screw-retained and Esthetics, run by Junyu Shi 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 6 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 7 Sep 2020. 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?
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?
Marginal bone loss (time frame: 1year). 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 7 Sep 2020.