Extended Platelet Rich Fibrin or Hyaluronate Enriched Xenografts for Horizontal Ridge Augmentation Via Subperiosteal Tunneling (E-PRF)

Extended platelet rich fibrin or hyaluronate enriched xenografts will be used for horizontal maxillary ridge augmentation via subperiosteal tunneling to allow placement of dental implants six months later.

Study Overview

• Status: Completed
• Conditions: Dental Implant
• Intervention / Treatment: Combination product: bovine bone mixed with hyaluronate; Combination product: bovine bone mixed with E-PEF

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Egypt
    • Al Mansurah, Egypt, Egypt, 35516
      • Mansoura University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• a maxillary anterior or premolar narrow ridge (width 3-6 mm), and adequate bone height (>8 mm), seeking horizontal augmentation & dental implant rehabilitation

Exclusion Criteria:

• systemic contraindications to surgery, local infection, untreated periodontal disease, heavy smoking, or pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hyaluronate Group; Horizontal maxillary augmentation via subperiosteal tunneling using bovine bone and hyaluronate	Combination product: bovine bone mixed with hyaluronate; cerabone plus will be inserted as a graft material via subperiosteal tunneling of thin maxilla
Experimental: Extended Platelet Rich Fibrin Group; horizontal maxillary augmentation via subperiosteal tunneling using bovine bone and extended platelet rich fibrin	Combination product: bovine bone mixed with E-PEF; bovine bone mixed with E-PEF will be inserted as a graft material via subperiosteal tunneling of thin maxilla

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
horizontal bone gain measurement	CBCT will be used to measure horizontal bone width of the surgical site (in mm) at 3 points: at level of the crest, 2 mm and 6mm apical to the crest.	6months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone density measurement	Bone density will be assessed in HU by CBCT by using on demand 3D program	6 months, 12 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: R.25.12.94

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No