Osteogenic Potential of Schneiderian Membrane

NCT06766292 | Completed

• 1 other identifier: 672/2023
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Maxillary sinus augmentation is commonly performed by creating a space below the Schneiderian membrane which is further filled using autografts, bone graft substitutes, or a combination of both to allow for new bone formation. Recently, a new method called non-grafting sinus floor augmentation has been introduced as an alternative approach. This method is based on the idea of elevating the membrane and supporting it through implant insertion or the use of space-maintaining devices like titanium screws or mesh. This study was conducted to evaluate the efficacy of new bone formation after sinus floor elevation using space maintaining resorbable pins without graft material.

Conditions

Bone Healing; Sinus Membrane Osteoginicity

Keywords

sinus lifting; maxillary sinus augmentation

Outcome Measures

Primary Outcomes (1)

• bone height

  will be measured using CBCT (Cone Beam Computed Tomography)

  8 months

Secondary Outcomes (1)

• histological analysis

  8 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

in this group, the patients underwent open sinus lifting surgery and augmentation of the sinuses by xenograft without any additives

Procedure: open sinus lifting with xenograft only

study group

EXPERIMENTAL

In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained.

Procedure: primary intervention

Interventions

primary intervention PROCEDURE

In the study group: 2.0 mm screws were fixed to the lateral wall of the sinus above the superior osteotomy and placed buccopalatally where the schneiderian membrane was elevated and maintained. this technique will suspends the membrane in position to allow the blood clot to organized and formation of bone.

study group

open sinus lifting with xenograft only PROCEDURE

ll Patients in this group underwent open sinus procedures to lift the sinus membrane followed by application of the xenograft as an augmentation material xenograft is used instead of autogenous bone graft to avoid the morbidity of the donor side

Control Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male/female patients above the age of 25.
• Patients with one or more teeth requiring implant supported dental restoration in atrophic maxilla (unilateral or bilateral).
• Alveolar bone height less than 4 mm at the defective site.
• Good oral hygiene.

You may not qualify if:

• Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
• Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
• Heavy smokers.
• Patients not indicated for an implant supported restoration at the time of enrollment (eg. active/untreated periodontal disease).

Sponsors & Collaborators

• rehab soliman: lead

Study Sites (1)

Suez Canal University

Ismailia, 41522, Egypt

Location

Study Officials

• rehab soliman

  Misr International University

  PRINCIPAL INVESTIGATOR

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 INVESTIGATOR
• PI Title: lecturer of oral and maxillofacial surgery

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: August 27, 2023
• Primary Completion: August 3, 2024
• Study Completion: September 3, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)