Effect Of Occlusal Materials Used For All On Four Mandibular Implant Prosthesis With PEEK Framework

NCT06159530 | Completed DMC

• 1 other identifier: A03021121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study was performed to compare between the effects of different occlusal materials used for all on four implant supported mandibular fixed prosthesis with PEEK framework. Methods of Evaluation 1- Occlusal force analysis using digital occlusal device (occluscan). The evaluation periods will be done at time of insertion (T0),6 month (T1),12 month(T2) and 18 month(T3) after framework insertion.

Conditions

Occlusal Trauma

Outcome Measures

Primary Outcomes (1)

• occlusal stability

  Occlusal stability using digital occlusal device (occlusense)

  The evaluation periods will be done at time of insertion (T0), 6 month (T1), 12 month (T2) and 18 month (T3) after framework insertion

Study Arms (2)

PEEK framework veneered with nanocomposite resin(visio-lign)

EXPERIMENTAL

patients recieved 4 implants according to All on 4 concept then peek framework was delivered and veneered with nano-composite resin (visio-lign) as an occlusal material

Procedure: dental implants; Procedure: peek framework; Procedure: visio-lign nano composite

PEEK framework veneered with zirconia crowns

EXPERIMENTAL

patients recieved 4 implants according to All on 4 concept then peek framework was delivered and veneered with zirconia crowns as an occlusal material

Procedure: dental implants; Procedure: peek framework; Procedure: zirconia crowns

Interventions

dental implants PROCEDURE

4 dental implants placed in the mandible according to all-on 4 concept

PEEK framework veneered with nanocomposite resin(visio-lign); PEEK framework veneered with zirconia crowns

peek framework PROCEDURE

peek framework screwed to multi-unit abutments of 4-implants

PEEK framework veneered with nanocomposite resin(visio-lign); PEEK framework veneered with zirconia crowns

visio-lign nano composite PROCEDURE

peek framework veneered with nano composite (visio-lign) as an occlusal material

PEEK framework veneered with nanocomposite resin(visio-lign)

zirconia crowns PROCEDURE

peek framework covered with zirconia crowns as an occlusal material

PEEK framework veneered with zirconia crowns

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lack of satisfaction of mandibular conventional dentures due to denture instability. 2- Atrophy of mandibular ridges with insufficient bone. 3- They were healthy, free from any systemic diseases relating to bone resorption. 4- All patients have sufficient inter-arch space \>15 mm. 5- Maxillary and mandibular residual alveolar ridges covered by healthy non-inflamed mucosa with even compressibility. 6- Normal maxilla-mandibular relationship (class I Angle's classification). 7- All patients will have mandibular bone height not less than 8-10mm as verified by cone beam CT. 8- Sufficient inter-arch space not less than 23 mm as verified by tentative jaw relation. And restorative space not less than14 mm as verified by putty index technique.

You may not qualify if:

• Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis). 2- Local or general contraindication for surgical procedures. 3- History of chemotherapy or radiation therapy to the head and neck area. 4- Habits as heavy smoking and alcoholism. 5- Patients with T.M.J disorders or poor neuromuscular co-ordination.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of dentistry

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mansoura U Faculty of dentistry

  Mansoura University Faculty of Dentistry, Prosthodontics department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: January 20, 2022
• Primary Completion: September 4, 2023
• Study Completion: October 10, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

EG (1)