Clinical trial NCT06965517: Effect of Digital Versus Static Jaw Relation Record on Crestal Bone Changes Around Implants Supporting Maxillary Single Overdenture
Official title: Effect of Digital Versus Static Jaw Relation Record on Crestal Bone Changes Around Implants Supporting Maxillary Single Overdenture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Jaw
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 14
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 implants inserted in fully edentulous maxilla, then loading with ball abutments for maxillary overdenture
Primary purpose: TREATMENT

Brief summary: patients will be equally and randomly divided into 2 groups. Each group contains seven patients: Digital Group: implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation.

Static Group: implant supported maxillary overdenture will be constructed using the conventional jaw relation method.

Radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique.

All data of radiographic evaluation were collected and tabulated then statistically analyzed using SPSS software.

Detailed description: * Conventional single upper denture will be made for all patients.
* Occlusal adjustment of lower teeth for all patients by T-scan using the single upper conventional denture.
* The single maxillary denture will be duplicated with radiopaque markers and CBCT will be used to determine the exact positions of the implants.

Surgical procedures

1. Surgery will be done under local anesthesia.
2. Drilling will be carried out under copious sterile irrigation.
3. four implants will be inserted in canines and second premolar area in the maxilla.

After 3-4 months of implants placement, patients will be equally and randomly divided into 2 groups. Each group contains seven patients:

Digital group: For this group, implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation.

Static group: For this group, implant supported maxillary overdenture will be constructed using the conventional jaw relation method.

Post insertion:

* Clinical evaluation for any signs of inflammation is made.
* Further occlusal refining of lower teeth by T-scan is done with final overdenture.

Method of evaluation:

Radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique.

All data of radiographic evaluation were collected and tabulated then statistically analyzed using SPSS software.

Eligibility criteria: Inclusion Criteria:

* Age: under 60 years.
* Completely edentulous maxillary arch.
* Opposing natural dentition in the mandibular arch.
* Residual mandibular ridge has adequate bone and covered by firm healthy mucosa.
* Class I maxillary-mandibular relationship.
* Normal salivary flow with normal viscosity.
* Systemically free patients.

Exclusion Criteria:

* Patients with poor oral hygiene.
* Patients with abnormal oral habits as (bruxism, clenching, tongue thrusting).
* Bone or mucosal diseases.
* Metabolic diseases or uncontrolled diabetes and TMJ disorders.
* Conditions that may complicate the treatment like; large tongue, gagging reflex and limited mouth opening.
* Patients who are smokers.

Primary outcomes:
measure: Marginal bone loss around implants
timeFrame: 18 month
Secondary outcomes:
measure: digital occlusal analysis using T-scan
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
Study officials:
affiliation: Faculty of Dentistry, Ain Shams University
name: Lamiaa GA Saleh, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: