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

NCT04539912 | Completed

• 1 other identifier: sh9th-20-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  1year

Secondary Outcomes (8)

• Survival rate.

  1 year

• Pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)

  1 year

• Mechanical complications

  1 year

• pocket probing depth(PD)

  1 year

• PES/WES

  1 year

Study Arms (2)

angulated screw-retained group(AG)

EXPERIMENTAL

Device: angulated screw retained crown

cemented group (CG)

ACTIVE COMPARATOR

Device: cemented crown

Interventions

angulated screw retained crown DEVICE

ASC abutment was used in AG;

angulated screw-retained group(AG)

cemented crown DEVICE

prefabricated Ti abutment was used in CG

cemented group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age≥18;
• \) Single dental implant in the esthetic region;
• \) adjacent to natural teeth;
• \) absence of oral mucosal disease and oral infection;
• )implants withconical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
• )patients with the willingness of all-ceramic permanent restorations.

You may not qualify if:

• )Multiple implants in the esthetic region, or the restoration is a bridge;
• )Heavy smokers (\>10 cigarettes/day);
• \) the angle between implant axis and restoration axis\>25°;
• \) uncontrolled periodontitis;
• \) 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;
• \) Unwilling to participate in the present study.

Sponsors & Collaborators

• Junyu Shi: lead

Study Sites (1)

Jun-Yu Shi

Shanghai, Shanghai Municipality, 200011, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

CN (1)