Effect of Slopped Shoulder Implant Neck vs Conventional Implant Neck Design on Crestal Bone Level in the Maxilla

NCT03614442 | Unknown

• 1 other identifier: platform switching 2018
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching.The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues.

Conditions

Missing Tooth

Outcome Measures

Primary Outcomes (1)

• pink esthetic score(PES)

  soft tissue esthetics scale : Seven variables will be evaluated vs. a natural reference tooth: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14.

  8 months

Secondary Outcomes (2)

• crestal bone resorption

  8 months

• implant stability

  8 months

Study Arms (2)

slopped shoulder implant

EXPERIMENTAL

The osteotomy site will be prepared using appropriate drill sizes with flapless approach, The implant (conventional neck implant design )will be inserted till the platform will be flushed with the crestal bone, The primary stability will be checked using torque wrench

Other: slopped shoulder implant

conventional implant with flat platform

ACTIVE COMPARATOR

inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench

Other: slopped shoulder implant

Interventions

slopped shoulder implant OTHER

different implant design to enhance soft and hard tissue outcome

conventional implant with flat platform; slopped shoulder implant

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good oral hygiene
• Systemically healthy (free from any systemic diseases).
• Adequate native bone to achieve implant primary stability
• Have had the tooth extraction at least 3 months before implant surgery.
• Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery

You may not qualify if:

• Smokers
• Pregnant woman
• Had a history of alcoholism or drug abuse within the past 5 years.
• Had bruxism or clenching habits.
• Patients who refused to join the study.
• Had significant untreated periodontal disease or history of treated periodontitis.
• Had caries on teeth adjacent to the prospective implant site.
• Periapical infection.
• localized radiation therapy of the oral cavity; antitumor chemotherapy.
• poor oral hygiene

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the design of the dental implant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.Sc. in Oral and Dental Medicine

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 3, 2018
• Study Start: July 30, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-07