GFRC Enhance Patient Satisfaction and Reduce Complications in Maxillary Implants With Pekkton Frameworks

NCT06581354 | Not Yet Recruiting

• 1 other identifier: 2 1 24
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the effect of provisionalization with a glass fiber composite framework on patient satisfaction and prosthetic complications before the insertion of a definitive PEKKTON framework when used under the screw-retained maxillary implant-supported prostheses at a one-year follow-up period.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  During the 12-month follow-up period as follows (3 months after delivery, 6 months after delivery, and 12 months after delivery), Patient satisfaction for Implant-supported screw-retained full arch maxillary provisional prosthesis with early loading protocol utilizing 6 implants for constructing a resin glass fiber composite followed by (PEKKTON) framework will be registered and calculated by Questionnaire

  one year

Secondary Outcomes (1)

• prosthetic complications

  one year

Study Arms (2)

no provisional prosthesis, pekkton is a definitive framework.

ACTIVE COMPARATOR

Implant-supported, full-arch maxillary prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization

Procedure: PROVISIONALIZATION

Glass fiber composite framework for provisionalization then pekkton framework.

EXPERIMENTAL

Implant-supported full arch maxillary provisional prosthesis protocol utilizing 6 implants for constructing a resin glass fiber composite framework followed by a definitive PEKKTON framework.

Procedure: PROVISIONALIZATION

Interventions

PROVISIONALIZATION PROCEDURE

glass fiber composite as a temporary framework followed by PEKKTON definitive framework.

Glass fiber composite framework for provisionalization then pekkton framework.; no provisional prosthesis, pekkton is a definitive framework.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Completely edentulous patients with Angle's Class I maxillomandibular relationship b. Age ranges from 40 to 65 years old. c. Adequate zone of keratinized attached mucosa (≥ 8mm) over the maxillary crest.
• d. Absence of any medical disorder that could complicate the surgical phase or affect osseointegration.
• e. The patient must have enough bone height for implants, a minimum length of bone f. 12 mm, and a minimum diameter of bone 6 mm. g. Patients with good oral hygiene. h. Complete denture wearer. i. Adequate interarch space for screw-retained prosthesis. j. Absence of any intra-oral pathological condition.

You may not qualify if:

• \- a. Patients with recent extraction (less than three months). b. Patients with an inflamed ridge or candida infection c. Patients with the flabby ridge. d. Para functional habits. e. Cancer patients receiving chemotherapy and/or radiotherapy. f. Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c ≥ 7) g. Potentially uncooperative patients who are not willing to go through the proposed interventions.
• h. Moderate-to-heavy daily smokers (more than ten per day)

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• rana shehata, phd

  faculty of dentistry Cairo university -Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sheta

CONTACT

+201224552363; nora.sheta@dentistry.cu.edu.eg

Huda Fakhry, lecturer

CONTACT

+201006229611; huda.fakhry@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will be based on different technical procedures for the fabrication of the frameworks. Since these differences are visible, the operator and the technician involved in the study as well as the outcome assessor cannot be blinded. But the statistician and patients will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator (assistant lecturer of prosthodontics)

Model Details: Group I: Intervention will be treated using a glass fiber composite as a temporary framework followed by PEKKTON definitive framework. Group II: Controls will be treated using PEKKTON definitive framework (no provisionalization).

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share