Digital Versus Conventional Impression CAD\CAM Constructed 4- Implant Supported Mandibular Overdenture Base

NCT06071676 | Completed

• 1 other identifier: M01010322
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study was done to compare between digital with conventional impression used in the CAD/CAM constructed 4- implant supported mandibular overdenture base regarding their effect on the bone height changes

Conditions

Implant Complication

Outcome Measures

Primary Outcomes (1)

• Bone height changes

  Long cone paralleling technique and a film holder designed specifically for implant imaging were used for intraoral radiograph. To maintain the same film- implant distance and cone implant distance, a modification was carried out for the film holder. This modification is a hole drilled exactly above the implant fixture so the distance was maintained during subsequent film exposures. A long screw of the impression coping was used to secure the holder to the implant. Through this modification, standardized radiographs were achieved.

  one year

Study Arms (2)

conventional impression procedures

OTHER

Implant analogues were screwed to the transfer copings inside the impression and the master cast were obtained. Attachments were screwed to the analogues and metal housing wasplaced on their position on master cast. Master cast will be scanned extra orally to obtain STL file of the master cast.

Other: conventional impression group

digital impression procedures

OTHER

A digital scanner (shining 3D scanner, Germany) was utilized to fabricate the definitive prostheses. The attachments were screwed to the implants intra orally and metal housing on their position which scanned by using intra oral scanner. * Intra oral scanner transformed into a virtual volume the three-dimensional geometry of dental arches using the principle of structured light. A scanning stitching strategy carried out by the same experienced investigator and applied to DIG group for the attachments on their position on implants. * The software automatically was applied a stitching algorithm in order to merge the two halves, based on the area between the two anterior implants, shared by both the separate scans. * The virtual model was created of the dental implant and attachments in position which used to obtain 3d printed master cast by using 3D printer (WANHAO desktop 3D printer, Zhejiang, China).

Other: digital impression group

Interventions

conventional impression group OTHER

Silicon impression material loaded on plastic tray and inserted inside the patient mouth

conventional impression procedures

digital impression group OTHER

direct scanning was done using intraoral scanner to the female housing of the attachments on position

digital impression procedures

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patient wearing maxillary conventional denture.
• All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
• A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
• They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
• At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
• All patients are of angel's class I maxillo-mandibular relationships.

You may not qualify if:

• Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
• Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
• Long term immunosuppress and corticosteroid drug therapy.
• Patient with abnormal habits as clenching and bruxism.
• Smoking patient.
• Uncooperative patients.
• Neuromuscular diseases.
• Patient with problems in TMJ.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Egypt

Location

Related Publications (1)

• Goracci C, Franchi L, Vichi A, Ferrari M. Accuracy, reliability, and efficiency of intraoral scanners for full-arch impressions: a systematic review of the clinical evidence. Eur J Orthod. 2016 Aug;38(4):422-8. doi: 10.1093/ejo/cjv077. Epub 2015 Oct 20.

  PMID: 26487391 RESULT

Related Links

• Accuracy, reliability, and efficiency of intraoral scanners for full-arch impressions

Study Officials

• mohamed fouad, professor

  specify Unaffiliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 6, 2023
• Study Start: February 20, 2022
• Primary Completion: January 6, 2023
• Study Completion: February 7, 2023
• Last Updated: October 17, 2023

Record last verified: 2022-02

Locations

EG (1)