Patient Satisfaction , Marginal Adaptation And Biocompatibility of Milled Biohpp Polyetheretherketone (PEEK) Single Anterior Crowns Veneered With Two Different Techniques.

NCT04914325 | Completed Phase 4 DMC

• 1 other identifier: 241020
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Research question For patients in a need for anterior crown, does the use of Milled BioHPP PEEK copings veneered with CAD/CAM composite resin offer better patient satisfaction, marginal adaptation and biocompatibility when compared Milled BioHPP PEEK copings veneered with manual layering? Statement of the problem PEEK exhibits a unique modulus of elasticity close to human bone/dentine so it acts as a shock absorber with stress reducing effect. Moreover from a biologic point of view, PEEK is highly compatible with surrounding tissues and it has very promising surface properties . The use of peek in anterior area is limited due to its opaque nature and grayish color, this drawback has been overcome by the use of composite layering material . PEEK restorations can be veneered with manual or CAD/CAM techniques. Information is lacking regarding the influence of the veneering technique on the patient satisfaction , precision of fit and biocompatibility of these restorations which will in turn influence their performance in patient's satisfaction. Rationale To achieve high esthetics when using PEEK it must be veneered by esthetic material 3 . It is available to be used manually or to be milled by CAD/CAM. The manual veneering of the PEEK coping with composite might affect the marginal integrity and the surrounding gingival tissues leading to decrease in the patient satisfaction, while the CAD/CAM veneering technique is proposed to have better patient satisfaction , marginal adaptation and an excellent biocompatible effect on the surrounding tissue. The importance of this trial lies in providing an alternative solution to the manual veneering technique, which will, in-turn, provide better restoration longevity results Aim of the study: The aim of this study is to evaluate the patient satisfaction ,marginal adaptation and biocompatibility of milled BioHPP PEEK copings veneered with CAD/CAM composite resin and compare them to milled BioHPP PEEK copings veneered with manual layering. Null hypothesis: There is no difference in the patient satisfaction, marginal adaptation and biocompatibility between milled BioHPP PEEK copings veneered with CAD/CAM composite resin and milled BioHPP PEEK copings veneered with manual layering. Primary objective: - The Primary outcome: : patient satisfaction of the two groups will be assessed by rating score 0 unaccepted , 1 good , 2 excellent - Secondary outcome: Marginal adaptation of the two groups will be assessed using the modified Ryge criteria. - Tertiary outcome: Biocompatibility (Bleeding). Signs of inflammation and bleeding of the two groups will be recorded after clinical examination and probing using periodontal probe Trial design: - Randomized clinical trial Eligibility criteria: Inclusion criteria: All subjects are required to be: 1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients in a need for anterior crown. 5- Able to return for follow-up examinations and evaluation Exclusion criteria 1\. Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal diseases 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5. Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or unrealistic expectations

Conditions

Patient Satisfaction; Gingival Bleeding

Outcome Measures

Primary Outcomes (1)

• patient satisfaction of the two groups will be assessed

  rating score 0 unaccepted , 1 good , 2 excellent

  one year

Secondary Outcomes (1)

• Marginal adaptation of the two groups will be assessed u

  one year

Other Outcomes (1)

• Biocompatibility (Bleeding)

  one year

Study Arms (2)

Intervention arm :copings veneered with CAD/CAM composite resin

EXPERIMENTAL

Combination Product: peek

Control arm : copings veneered with manual layering

ACTIVE COMPARATOR

Combination Product: peek

Interventions

peek COMBINATION_PRODUCT

After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction

Control arm : copings veneered with manual layering; Intervention arm :copings veneered with CAD/CAM composite resin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects are required to be:
• From 18-50 years old, be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases, have teeth with good restorations
• Psychologically and physically able to withstand conventional dental procedures
• Patients in a need for anterior crown.
• Able to return for follow-up examinations and evaluation -

You may not qualify if:

• Patient less than 18 or more than 50 years
• Patient with active resistant periodontal diseases
• Patients with poor oral hygiene and uncooperative patients
• Pregnant women
• Patients in the growth stage with partially erupted teeth
• Psychiatric problems or unrealistic expectations -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Salah

Cairo, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction; Gingival Hemorrhage

Interventions

polyetheretherketone

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investegator

Model Details: 1\. Recording the sulcus depth and gingival condition prior to preparation. 2. Conservative tooth preparation will be prepared after local anesthesia has been given as required. 3. Full coverage preparation will be carried out . 3. After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction.

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 4, 2021
• Study Start: October 22, 2021
• Primary Completion: January 22, 2023
• Study Completion: January 22, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)