The Effect of Fiber-Reinforced Composites on Quality of Life and Bone Height in Maxillary Implant Arches

NCT06576778 | Not Yet Recruiting

• 1 other identifier: 3 1 24
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is assessing the effect of provisionalization with a glass fiber composite framework on patients' quality of life and bone height changes before the insertion of a definitive PEKKTON framework of screw-retained maxillary implant-supported prosthesis at a one-year follow-up period.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• Oral health related to quality of life

  A translated form from a validated questionnaire will be used to address the Egyptian population; all patients have to answer the same questionnaire. Each answer will be given a score from 0 to 4 where the lesser the score the better the quality of life, data will be collected, and privacy will be ensured.

  1 year

Secondary Outcomes (1)

• Bone height changes assessments

  1 year

Study Arms (2)

No Provisional Prosthesis (PEKKTON as Definitive Framework)

ACTIVE COMPARATOR

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

Procedure: PROVSIONALIZATION

Glass Fiber Reinforced Composite Framework for Provisionalization Then PEKKTON Framework

EXPERIMENTAL

Implant-supported full arch maxillary prosthesis utilising 6 implants, then Glass fiber composite as a temporary framework followed by PEKKTON definitive framework.

Procedure: PROVSIONALIZATION

Interventions

PROVSIONALIZATION PROCEDURE

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

Glass Fiber Reinforced Composite Framework for Provisionalization Then PEKKTON Framework; No Provisional Prosthesis (PEKKTON as 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:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Haydi Issa, PhD

  faculty of dentistry, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheta

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 is based on different technical procedures of framework fabrication. Since these differences are visible, the operator and the patients involved in the study cannot be blinded. But the outcome assessor and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator ( assistant lecturer of prosthodontics)

Model Details: Group I, (control): patients obtained an Implant-supported, full arch maxillary definitive prosthesis utilizing 6 implants, for constructing PEKKTON framework without provisionalization. Group II, (intervention): Patients obtained an 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.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share