Clinical Efficacy of Angulated Screw-retained and Cemented Single Implant Crowns in Esthetic Region

NCT ID: NCT04539912

Last Updated: 2020-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Angulated Screw-retained Esthetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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angulated screw-retained group(AG)

Group Type EXPERIMENTAL

angulated screw retained crown

Intervention Type DEVICE

ASC abutment was used in AG;

cemented group (CG)

Group Type ACTIVE_COMPARATOR

cemented crown

Intervention Type DEVICE

prefabricated Ti abutment was used in CG

Interventions

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angulated screw retained crown

ASC abutment was used in AG;

Intervention Type DEVICE

cemented crown

prefabricated Ti abutment was used in CG

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Junyu Shi

OTHER

Sponsor Role lead

Responsible Party

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Junyu Shi

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jun-Yu Shi

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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sh9th-20-09

Identifier Type: -

Identifier Source: org_study_id

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