Titanium Prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation

NCT06135077 | Completed

• 1 other identifier: 0301_10/2021
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination. This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.

Conditions

Sinus Lifting

Outcome Measures

Primary Outcomes (4)

• Change in pain level

  measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.

  up to 2 weeks

• Change in bone volume

  pre opertaive and post operative CBCT

  up to 3 months

• Change in bone denisty

  pre opertaive and post operative CBCT

  up to 3 months

• Change in bone height

  pre opertaive and post operative CBCT

  up to 3 months

Study Arms (2)

T-PRF

EXPERIMENTAL

Other: T-PRF alone

T-PRF/xenograft

ACTIVE COMPARATOR

Other: T-PRF/Xenograft

Interventions

T-PRF alone OTHER

T-PRF is the material to be tested in this study as an alternative to classical bone graft

T-PRF

T-PRF/Xenograft OTHER

One part of T-PRF will be divided into minute pieces to be mixed with xenograft

T-PRF/xenograft

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically in a healthy condition.
• Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
• Non-smokers.
• Good oral hygiene as indicated by plaque and bleeding scores

You may not qualify if:

• Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
• Acute maxillary sinusitis.
• Patients administering any antibiotics or regular anti-inflammatory drugs.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: November 11, 2021
• Primary Completion: March 21, 2023
• Study Completion: March 21, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

EG (1)