NCT07412535

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

January 14, 2026

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • bone density measurement

    6 months, 12 months

Study Arms (2)

Hyaluronate Group

ACTIVE COMPARATOR

Horizontal maxillary augmentation via subperiosteal tunneling using bovine bone and hyaluronate

Combination Product: bovine bone mixed with hyaluronate

Extended Platelet Rich Fibrin Group

EXPERIMENTAL

horizontal maxillary augmentation via subperiosteal tunneling using bovine bone and extended platelet rich fibrin

Combination Product: bovine bone mixed with E-PEF

Interventions

cerabone plus will be inserted as a graft material via subperiosteal tunneling of thin maxilla

Hyaluronate Group
bovine bone mixed with E-PEFCOMBINATION_PRODUCT

bovine bone mixed with E-PEF will be inserted as a graft material via subperiosteal tunneling of thin maxilla

Extended Platelet Rich Fibrin Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University, Faculty of Dentistry

Al Mansurah, Egypt, 35516, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of oral and maxillofacial surgery

Study Record Dates

First Submitted

January 14, 2026

First Posted

February 17, 2026

Study Start

March 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations