Clinical Performance of All-on-4 PEEK and Conventional Prostheses

NCT06388395 | Enrolling By Invitation DMC

• 1 other identifier: REC-23-05-12-02-F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The all-on-4 treatment approach for completely edentulous mandible is a proven concept. However, there are still issues regarding the use of metal substructure to support the prostheses such as allergy, metallic taste, and aesthetic. Therefore, other materials such as polyetheretherketone (PEEK) are being tested for its suitability and is showing good potential. However, available evidence is limited regarding its clinical performance. Thus, the aim of this study is to compare clinical performance of all-on-4 treatment concept utilizing PEEK versus conventional metal framework as substructure in fully edentulous mandible. Thirty suitable patients will receive either PEEK or conventional all-on-4 prostheses for fully edentulous mandible. The prostheses will be retained by four implants utilizing the all-on-4 principle. Clinical performance will be assessed during the follow up period of up 3 years concerning screw loosening, material chipping or fracture, wear or staining, prosthesis survival and success, implant survival and success.

Conditions

Failure, Prosthesis; Dental Prosthesis, Implant-Supported; Survival, Prosthesis; Complete Edentulism; Complication;Prostheses

Outcome Measures

Primary Outcomes (4)

• Accuracy of full-arch surgical guides

  Two types of surgical guides will be assessed for the accuracy. CBCT scans before and after surgery will be imported into 3D inspection software (Geomagic, 3D Systems Inc., Rock Hill, SC) for merging and evaluation of 3D deviations. Following software best-fit alignment, the 3D comparison will be used to evaluate the 3D deviations between the scans limited to the implants. Root man square (RMS) deviations will be recorded.

  6 months

• Survival rate of implants

  Implant survival will be assessed clinically and radiographically every year. The criteria for implant success according to Buser et al, were no radiolucent zone around the implant, confirmed individual implant stability, and no suppuration, pain or ongoing pathologic processes (Buser et al., 1997). All implants that failed to fulfill these criteria will be regarded as failures.

  3 years

• Success rates of the Prostheses

  Successful prosthesis must be free from any of the following technical complications: screw loosening, screw fracture, veneer material fracture or chipping, bulk fracture. Kaplan-meier analysis will be used.

  3 years

• Pain level

  Anticipated and actual pain will be assessed before and after surgery using the 10-cm visual analog scale (VAS) ranging from 0 "no pain" to 10 "worst pain ever." The scale has no other markings along the line. Patients will be asked to record their pain level before surgery and after surgery, 24 hours after surgery, at day 2, day 4 and at week 1, week 2, and week 3.

  1 months

Secondary Outcomes (4)

• Marginal bone loss

  3 years

• Plaque index

  3 years

• Pocket depth

  3 years

• Bleeding index

  3 years

Study Arms (5)

Accuracy of full-arch surgical guides

EXPERIMENTAL

Two surgical guides (milled and 3D printed) will be used randomly to assess the accuracy of the guides following guided implant surgery.

Procedure: Accuracy of full-arch surgical guides

Survival and complications of the prostheses

EXPERIMENTAL

The clinical performance of the two different treatment concepts during the follow up period of 3 years concerning screw loosening, veneering material chipping, wear or staining, prosthesis survival and success will be assessed.

Procedure: Survival and complications of the prostheses

Survival and complications of the implants

EXPERIMENTAL

The implants survival and success rates will be evaluated after 1, 2 and 3 years of prostheses insertion.

Procedure: Survival and complications of the implants

Conventional implant-supported prosthesis

EXPERIMENTAL

Full-arch implant-supported conventional (metal-resin) prosthesis will be constructed and assessed for up to 3 years

Procedure: Conventional (metal-resin) implant-supported prosthesis

PEEK implant-supported prosthesis

EXPERIMENTAL

Full-arch implant-supported PEEK prosthesis will be constructed and assessed for up to 3 years

Procedure: PEEK implant-supported prosthesis

Interventions

Accuracy of full-arch surgical guides PROCEDURE

The accuracy of the surgical guides will be assessed by superimposing the pre and post-treatment CBCT scans.

Accuracy of full-arch surgical guides

Survival and complications of the prostheses PROCEDURE

Two different prostheses will be assessed (conventional and PEEK). All complications will be recorded for a period of 3 years

Survival and complications of the prostheses

Survival and complications of the implants PROCEDURE

The effect of the two different prostheses on implants will be assessed in terms of survival and success rates.

Survival and complications of the implants

Conventional (metal-resin) implant-supported prosthesis PROCEDURE

Full-mouth implant-supported conventional prosthesis will be constructed and evaluated for up to 3 years.

Conventional implant-supported prosthesis

PEEK implant-supported prosthesis PROCEDURE

Full-mouth implant-supported PEEK prosthesis will be constructed and evaluated for up to 3 years.

PEEK implant-supported prosthesis

Eligibility Criteria

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

You may qualify if:

• no contraindications for implant surgery (including uncontrolled systemic diseases)
• sufficient bone height in the inter-foraminal area for an implant length of at least 10 mm
• ridge width of 5.5 mm for implant insertion of at least 3.5 mm in diameter,

You may not qualify if:

• individuals who disagreed with being randomly allocated to the treatment study groups, those with signs of untreated temporomandibular disorders or uncontrolled systemic or oral conditions requiring additional treatment, participants unable to understand and answer the questionnaires used in the study, and unable to attend the scheduled post-treatment appointments for longitudinal data collection.

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

Sharjah city, 7724, United Arab Emirates

Location

Related Publications (9)

• Malo P, de Araujo Nobre M, Rangert B. Short implants placed one-stage in maxillae and mandibles: a retrospective clinical study with 1 to 9 years of follow-up. Clin Implant Dent Relat Res. 2007 Mar;9(1):15-21. doi: 10.1111/j.1708-8208.2006.00027.x.

  PMID: 17362493 BACKGROUND

• Patzelt SB, Bahat O, Reynolds MA, Strub JR. The all-on-four treatment concept: a systematic review. Clin Implant Dent Relat Res. 2014 Dec;16(6):836-55. doi: 10.1111/cid.12068. Epub 2013 Apr 5.

  PMID: 23560986 BACKGROUND

• Sailer I, Philipp A, Zembic A, Pjetursson BE, Hammerle CH, Zwahlen M. A systematic review of the performance of ceramic and metal implant abutments supporting fixed implant reconstructions. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:4-31. doi: 10.1111/j.1600-0501.2009.01787.x.

  PMID: 19663946 BACKGROUND

• Fabbri G, Sorrentino R, Brennan M, Cerutti A. A novel approach to implant screw-retained restorations: adhesive combination between zirconia frameworks and monolithic lithium disilicate. Int J Esthet Dent. 2014 Winter;9(4):490-505.

  PMID: 25289384 BACKGROUND

• Rubo JH, Capello Souza EA. Finite-element analysis of stress on dental implant prosthesis. Clin Implant Dent Relat Res. 2010 Jun 1;12(2):105-13. doi: 10.1111/j.1708-8208.2008.00142.x. Epub 2009 Feb 13.

  PMID: 19220846 BACKGROUND

• Ciftci Y, Canay S. The effect of veneering materials on stress distribution in implant-supported fixed prosthetic restorations. Int J Oral Maxillofac Implants. 2000 Jul-Aug;15(4):571-82.

  PMID: 10960992 BACKGROUND

• Davis DM, Rimrott R, Zarb GA. Studies on frameworks for osseointegrated prostheses: Part 2. The effect of adding acrylic resin or porcelain to form the occlusal superstructure. Int J Oral Maxillofac Implants. 1988 Winter;3(4):275-80. No abstract available.

  PMID: 3075967 BACKGROUND

• Gracis SE, Nicholls JI, Chalupnik JD, Yuodelis RA. Shock-absorbing behavior of five restorative materials used on implants. Int J Prosthodont. 1991 May-Jun;4(3):282-91.

  PMID: 1810320 BACKGROUND

• Stijacic T, Chung KH, Flinn BD, Raigrodski AJ. Effect of Tooth-Colored Restorative Materials on Reliability of Heat-Pressed Lithium Disilicate. J Prosthodont. 2015 Aug;24(6):475-83. doi: 10.1111/jopr.12243. Epub 2014 Dec 17.

  PMID: 25522165 BACKGROUND

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Ahmed Aziz, PhD

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Block randomization will be used to randomly assign participants. The sequences will be concealed in opaque, consecutively numbered envelopes for each block. One envelope will be obtained for each participant, corresponding to the assignment of the protocol (conventional versus PEEK). The outcome assessor will be independent and not involved in any treatment procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups will be provided with two types of implant-supported prostheses

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 29, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)