3D-printed Implant Overdentures

Not Applicable

Completed

• Conditions: Edentulous Mouth

• Registration Number: NCT04569929
• Lead Sponsor: October University for Modern Sciences and Arts

Brief Summary

A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants were randomly allocated into two equal groups. All participants received two implants in the inter-foraminal area with ball attachments. Participants in the control group were rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary complete denture and mandibular implant overdentures while participants in intervention group received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary complete denture and mandibular implant overdentures. Follow-up appointments were scheduled at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). In addition, denture retention was measured using digital force gauge device. Data were collected and statistically analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-06-05
• Study Completion: 2020-08-10
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-09-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• completely edentulous
• ranging in age from 50 to 65 years
• Angle's class I skeletal relationship, normal facial symmetry.
• Adequate quantity of bone (class IV -VI ) and quality (classes 1 - 3 ) in the mandibular inter-foraminal area to accommodate standard implants of at least 11 mm length and 3.7 mm diameter
• appropriate inter-arch space of at least 15 mm (class I ) to accept all types of tested dentures

Exclusion Criteria

Metabolic disorders affecting osseointegration such as hepatic disorders

• osteoporosis and diabetes mellitus.
• Temporomandibular disorders, anticoagulant therapy or bleeding disorders
• sharp mandibular residual ridge or flabby tissues
• neuromuscular disorders, and class II and III Angle's classification skeletal relationship
• Smokers and patients on chemotherapy or radiotherapy or suffering from psychiatric conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
. OHRQoL (oral health related quality of life)	12 months	Oral Health Impact Profile 19 (OHIPEDENT19) was used to assess the OHRQoL (oral health related quality of life). The questionnaire was translated to Arabic and validated (S2).24 The profile consisted of 19 questions each with score 0 to 4 (impaired) on Likert scale; accordingly, for each patient the minimum score was 0 and maximum score was 76.

Secondary Outcome Measures

Name	Time	Method
Overdentures' retention	12 months	The retention was measured at baseline (day of delivery), three months thereafter, after six months then after 12m by a digital force gauge device (Extech's Model 475055 Digital Force Gauge FLIR Commercial Systems, Inc.) that measures tension or compression force (pull/push) to values of up to 980 Newton.25 The snap hook of the device engaged a screw fixed to the geometric center of denture bases using self-cure acrylic resin. Then pulling action was applied till the denture separation recording the amount of retention in Newton.

Trial Locations

Locations (1)

Msa Uni; 🇪🇬 Giza, Egypt