The Use of Extended Platelet Rich Fibrin in Lateral Sinus Augmentation

NCT06626776 | Not Yet Recruiting

• 1 other identifier: A0102024OS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

1. 1.Clinical Evaluation
2. 2.Implant stability
3. 3.Radiographic Evaluation Vertical bone gain (VBG)

Conditions

Sinus Lift Augmentation

Outcome Measures

Primary Outcomes (2)

• implant stability

  the stability of the implants will be evaluated by RFA with the Osstell Mentor device.

  9 months

• Vertical bone height

  vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant

  6 months

Study Arms (2)

lateral sinus lift with bone augmenation

EXPERIMENTAL

Procedure: lateral sinus lift with using allograft and collagen membrane

lateral sinus lift with extended platelet rich fibrin

EXPERIMENTAL

Procedure: lateral sinus lift with using exteneded platelet rich fibrin

Interventions

lateral sinus lift with using allograft and collagen membrane PROCEDURE

sinus floor elevation with placing allograft and collagen membrane

lateral sinus lift with bone augmenation

lateral sinus lift with using exteneded platelet rich fibrin PROCEDURE

sinus floor elevation with placing eprf

lateral sinus lift with extended platelet rich fibrin

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patent ostium of maxillary sinus.
• Patient with missing one or more posterior maxillary teeth.
• Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
• A ridge width at the site of implantation of \<5mm.
• Platelets of normal range.
• Good oral hygiene.
• Patients in the age frame between 20 years and 60 years old.
• No gender preface in selection of the patients.
• A minimum crown height space of 8 mm.

You may not qualify if:

• Active sinusitis, cyst, tumors or root tips at the planned surgical site.
• Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
• Heavy smoking and alcoholism.
• Parafunctional habits such as bruxism and clenching.
• Signs of acute infection or pus discharge.
• Disturbed occlusion.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

MANSOURA University

Al Mansurah, Egypt

Location

Central Study Contacts

ammar samman

CONTACT

+201558990325; dr.3mmar@std.mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 4, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

EG (1)