(PEKK) Framework for Mandibular Implant-supported Complete Fixed Prostheses

NCT06164990 | Completed

• 1 other identifier: A01100522
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to evaluate the effect of using PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept on peri-implant tissues health

Conditions

Bone Loss; Peri-Implantitis

Outcome Measures

Primary Outcomes (4)

• peri-implant tissues health (Clinical)

  Modified gingival index

  1 year

• modified plaque index

  peri-implant tissues health (Clinical)

  1 year

• peri-implant probing depth

  Probing depth using plastic periodontal probe

  1 year

• Peri-implant radiographic evaluation

  Marginal bone height changes using periapical radiograph

  1 year

Study Arms (1)

PEKK (Pekkton) framework

EXPERIMENTAL

PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept and evaluated regarding peri-implant tissue health

Other: PEKK framework

Interventions

PEKK framework OTHER

PEKK (Pekkton) framework in mandibular implant-supported complete fixed dental prostheses with All-on-four treatment concept

PEKK (Pekkton) framework

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maxillary and mandibular alveolar ridges were covered with healthy, firm, relatively even thickness and even compressible mucosa and free from any signs of inflammation or flabbiness.
• Patients had completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height not less than 15 mm in the interforaminal area and at least 12mm posteriorly
• All patients had sufficient inter-arch space
• All patients complained of insufficient retention and stability of their conventional mandibular dentures.
• All patients were of Angel's class I maxillo-mandibular relationship.

You may not qualify if:

• Patients with absolute contraindications for implant placement, such as active cancer and diseases of the immune system.
• Patients with metabolic diseases that are directly related to bone resorption, such as uncontrolled diabetes, osteoporosis, and hyperparathyroidism.
• Patients with general contraindications for surgical procedures, such as hematologic diseases, hepatic patients, patients with bleeding disorders, and serious problems with coagulation.
• Patients with a history of irradiation of the head and neck region or chemotherapy in the last 3 years were also excluded.
• Patients with relative contraindications such as a history of parafunctional habits (such as bruxism and clenching), smoking, alcoholism, and patients with any physical reasons that could affect follow-up.
• Patients with local contraindications for implant placement, such as localized bone defects.

Sponsors & Collaborators

• Fatma mahanna: lead

Study Sites (1)

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Peri-Implantitis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of prosthodontics

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: May 10, 2022
• Primary Completion: June 15, 2023
• Study Completion: November 10, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)