Bio-implant Root Analogue Versus Conventional Screw-type Implant for Management of Pier Abutment in Mandibular Distal Extension Cases

NCT07284680 | Active Not Recruiting DMC

• 1 other identifier: A11061222
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

reviewing literature was lacking for bio implant and management of pier abutment in distal extension bases for this reason the aim of this research will be to use the bio implant in the management of pier abutment cases for distal extension denture base cases Aim of the study the aim of this study was to evaluate and compare the bioimplant root analogue implant with the conventional screw type implant the evaluation was done 0,3 and 6months of definitive prosthesis insertion regarding the following

1. 1.radiographic evaluation of the alveolar bone hight as related to the bio implant ,conventional screw implant , pier abutment and RPD abutments : this will be done using standardized periapical digital radiographs
2. 2.soft tissue evaluatins related to the bio implant ,conventional screw implant , pier abutment and RPD abutments this will be done using : A . modified plaque index (MPI) B . modified gingival index (MGI) C . peridontal pocket depth

Conditions

Implant Assesment

Outcome Measures

Primary Outcomes (1)

• bone changes and soft tissue changes

  peri-implant bone and soft tissue changes and abutment teeth bone and soft tissue changes changes periapical X-ray for measurement of bone changes by millimeter periodontal probe for measurement of soft tissue changes by millimeter

  after 3 and 6 months of denture insertion

Study Arms (2)

bioimolant

EXPERIMENTAL

bioimplant assessement

Device: Implant

screw type conventional implant

EXPERIMENTAL

conventional screw type implant assessement

Device: Implant

Interventions

Implant DEVICE

construction of prothesis related to bioimplant or conventional implant

bioimolant; screw type conventional implant

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients had bilateral mandibular free-end partially edentulous cases with a pier abutment or a planned presence of pier abutment.
• The edentulous space mesial to the pier abutment has a hopeless tooth or root that was used for bio-implant insertion or conventional screw-type implants.
• Healthy patients with no systemic disease that can affect the implant surgery. This was verified by medical history in addition to a report from the physician.
• The patients have had dentulous maxillary jaw and mandibular free-end saddle for at least 6 months.
• Class I maxillo-mandibular relationship with adequate inter-arch distance.

You may not qualify if:

• Patients with metabolic disorders that affect osseointegration such as uncontrolled diabetes mellitus, immune disorders, and osteoporosis.
• Patients with heavy smoking habit
• Patients complaining of severe temporomandibular joint disorder.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 7650001, Egypt

Location

MeSH Terms

Interventions

Mutagenesis, Insertional

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgrad student (master of prosthodontics)

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 16, 2025
• Study Start: December 19, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

EG (1)