Complete Edentulism
Conditions
Keywords
all-on-4, implant supported prosthesis, titanium framework, Nano-Carbon framework, CAD/CAM, peri-implant tissue, prosthetic complications
Brief summary
This clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses. Ten completely edentulous patients are randomly allocated into two equal groups. The study evaluates peri-implant soft tissue health, changes in marginal bone levels,and prosthetic complications over an 12-month follow-up period.
Detailed description
Completely edentulous patients receive four mandibular implants according to the All-on-4 concept, with two anterior axial implants and two posterior tilted implants placed anterior to the mental foramina. Patients are randomly allocated to receive either a CAD/CAM-milled titanium framework or a nano-carbon fiber-reinforced framework. Clinical follow-up includes assessment of modified plaque index, modified gingival index, probing depth, and bleeding index. Marginal bone level changes are assessed radiographically at 6 and 12 months after insertion of the fixed prosthesis. Prosthetic complications are also evaluated.
Interventions
DEVICETitanium CAD/CAM Framework
CAD/CAM-milled titanium framework used for mandibular All-on-4 implant-supported hybrid prosthesis.
DEVICENano-Carbon CAD/CAM Framework
Nano-carbon fiber-reinforced CAD/CAM framework used for mandibular All-on-4 implant-supported hybrid prosthesis.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* \* Completely edentulous patients requiring mandibular implant-supported rehabilitation. * Adequate bone quantity and quality in the mandibular interforaminal region for implant placement. * Adequate restorative space for an implant-supported hybrid prosthesis. * Healthy oral mucosa and acceptable oral hygiene. * Patients medically fit to undergo implant surgery. * Ability and willingness to attend the scheduled follow-up visits and provide informed consent.
Exclusion criteria
* Systemic conditions or medical contraindications that could interfere with implant surgery or healing. * History of radiotherapy to the head and neck region. * Smoking. * Alcohol abuse. * Bruxism or clenching habits. * Any local condition that could compromise implant placement or the planned prosthetic rehabilitation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal bone level change | At prosthesis insertion (T0), 6 months (T6), and 12 months (T12) | Radiographic assessment of changes in peri-implant marginal bone level around the implants in the titanium and nano-carbon framework groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified plaque index | At prosthesis insertion (T0), 6 months (T6), and 12 months (T12) | Assessment of plaque accumulation around the implants using the modified plaque index |
| Modified gingival index | At prosthesis insertion (T0), 6 months (T6), and 12 months (T12) | Assessment of peri-implant gingival tissue condition using the modified gingival index |
| Probing depth | At prosthesis insertion (T0), 6 months (T6), and 12 months (T12) | Measure of per-implant probing depth around the implants |
| Bleeding index | At prosthesis insertion (T0), 6 months (T6), and 12 months (T12) | Assessment of peri-implant bleeding using the bleeding index |
| prosthetic complications | up to12 months after prosthesis insertion | Assessment of prosthetic complications and maintenance requirements associated with the implant supported prosthesis |
Countries
Egypt
Outcome results
None listed