Soft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted

Peri-Implantitis Clinical Trial

Official title:

Soft Tissue Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Casted One (RCT, Split Mouth Design)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543864
• Other study ID #: 13420
• Status: Recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: November 2021

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: faculty of dentistry,cairo university Cairo university
• Phone: +20235676105
• Email: dentmail[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

comparing the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method

Description:

as joining multiple implants by a metal framework considered a solid solution for edentulous arches , but in the same time the conventional method to weld this metal framework to the implants by casting technique in lab usually involves a several disadvantages eg. cost and time consuming in addition to laboratory errors, Thus , this study aims to find another method to weld the metal framework intraorally by an electric welding device

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: November 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ages range from 45 to 65 years old.

• Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.

• The patients must be completely edentulous.

• The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.

• Patients with good oral hygiene.

• Complete denture wearer.

• Adequate inter arch space for screw retained prosthesis.

• Absence of any intra-oral pathological condition.

Exclusion Criteria:

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

• Patients with inflamed ridge or candida infection.

• Patients with flappy ridge.

• Parafunctional habits.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Device:
• Electric intraoral welding device
welding metal framework to the implants in completely edentulous maxilla by electric welding device intraorally
• casting
casting the metal framework

Locations

Country	Name	City	State
Egypt	Cairo University , Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft Tissue Changes Assessment	Primary outcome is the probing depth which will be measured using the periodontal probe (unit mm) around the implant to check the changes that may occur in the peri-implant soft tissues	12 months