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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• 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.

Disqualifiers

• Patients with recent extraction (less than three months).

Patients with an inflamed ridge or candida infection

Patients with the flabby ridge.

Para functional habits.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PROVSIONALIZATION

    Procedure/Surgery

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

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: No Provisional Prosthesis (PEKKTON as Definitive Framework)Active comparator 1 intervention
Group B: Glass Fiber Reinforced Composite Framework for Provisionalization Then PEKKTON FrameworkExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

1

Bone height changes assessments

Digital periapical radiographs (Digora System) at the time of implant loading, three months, six-months, one year post-operatively will be done utilizing periapical radiographs following the standardized long cone paralleling technique and evaluated. For further standardization, the same x-ray machine will be used at 8 milliamperes and 70 kilovolts for 0.6 seconds with a focal film distance of 35 cm. Marginal bone height changes around the implants will be evaluated using the measurement software system supplied with the Digora radiographs system.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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