CClinicalTrials.gg
CompletedNCT06159530Updated Dec 6, 2023

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

An interventional study of dental implants and peek framework in Occlusal Trauma, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to male participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jan 2022, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Male
01

Study 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.

Read the detailed description

thirty completely edentulous patients will be selected for the study from the outpatient's clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.

The patients will be selected according to the following criteria:

  1. 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.

Exclusion criteria included:

1- 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.

  1. For all patient's conventional complete denture will be constructed and adjusted for insertion and delivery.
  2. A cone beam C.T will be done for each patient to determine the bone quality and quantity.
  3. A surgical stent will be designed and fabricated to allow accurate implant placement of two axially placed anterior implants and two distally tilted posterior implants by about 30 degree to support mandibular overdenture.
  4. Surgical placement of implant fixtures on its sites will be done.
  5. Multiunit abutments were screwed to the distal implants.
  6. The conventional mandibular denture will be modified to act as immediate fixed prosthesis that replace lost teeth and gingival tissues.
  7. After three months, the Polyetheretherketone (PEEK) frame that connects the four implants will be constructed using digital scan and CAD CAM manufacturing.
  8. The milled frame was fixed to the metal caps using DTK cement
  9. The BioHPP framework will have prepared abutments projecting from it. After processing, the framework will be tried in patient mouth for passive fit.
  10. Wax interocclusal record was made to establish the occlusal relationship with opposing teeth.

    According to the artificial teeth, the patients will be divided into two groups:

    • Group (I): PEEK framework veneered with nanocomposite resin(visio-lign)
    • Group (II): PEEK framework veneered with zirconia
  11. The inner surface of the artificial teeth will be etched using hydrophosphoric acid then silane will be used and light cured resin cement will be used for cementation of the artificial teeth to the PEEK framework
  12. The occlusal scheme used with the opposing maxillary denture will be lingualized balanced occlusion to enhance the stability of mandibular implant overdentures.

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.

02

Conditions studied

  • Occlusal Trauma
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 1- 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.

Exclusion criteria

Exclusion Criteria:

  • 1- 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    PEEK framework veneered with nanocomposite resin(visio-lign)

    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

  • Experimental
    PEEK framework veneered with zirconia crowns

    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

  • Proceduredental implants

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

  • Procedurepeek framework

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

  • Procedurevisio-lign nano composite

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

  • Procedurezirconia crowns

    peek framework covered with zirconia crowns as an occlusal material

06

What researchers measure

Primary outcomes

  1. occlusal stability

    Occlusal stability using digital occlusal device (occlusense)

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

07

Study locations

1 site
  • Mansoura University, Faculty of dentistry
    Mansoura, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06159530
Lead sponsor
Mansoura University
Responsible party
Mohamed shady (Assistant Professor, Mansoura University) — Principal investigator
First posted
Dec 6, 2023
Start date
Jan 20, 2022
Primary completion
Sep 4, 2023
Completion
Oct 10, 2023
Last update
Dec 6, 2023

Study contacts

Mansoura U Faculty of dentistry
principal investigator · Mansoura University Faculty of Dentistry, Prosthodontics department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion