Implant Placement Using Open Sinus Elevation Technique With and Without Bone Grafting Material

NCT06207604 | Not Yet Recruiting

• 1 other identifier: IDCE.N8
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The success rate of dental implants after graftless sinus augmentation versus conventional sinus augmentation surgery in atrophic maxillae in edentulous patients was investigated and it was concluded that despite the bone gain in ten garftless side, implant survival were significantly lower in the non-grafted side. One year later, Lie et al., conducted a systematic review to evaluate efficacy of graftless maxillary sinus membrane elevation using the lateral window approach for implantation in the atrophic maxilla. It showed a high implant survival rate in non-grafted maxillary sinus lifts and conventional sinus lifts using augmentation materials and there was no significant difference in the ISQ values between both procedures. However, further randomized clinical trials with long-term follow-up were recommended.

Conditions

Sinus Elevation

Keywords

dental implants; bone grafting; posterior maxilla

Outcome Measures

Primary Outcomes (1)

• Long- term Implant Stability

  Resonance frequency analysis will be employed with a dedicated device (Osstell).

  12 months

Secondary Outcomes (2)

• Implant survivability

  12 months

• Vertical bone height formed

  12 months

Study Arms (2)

Open sinus lifting without bone grafting and simultaneous implant placement

EXPERIMENTAL

When adequate release of the membrane is achieved and deemed enough by the operator, an osteotomy is created in the edentulous area following the drilling sequence provided by the implant system used. the implant placement is done directly with the implant motor and the use of a hand driver if needed to adjust the implant platform relation to the crestal bone, followed by cover screw placement.

Procedure: Open sinus lifting without bone grafting and simultaneous implant placement

Open sinus lifting with bone grafting and simultaneous implant placement

ACTIVE COMPARATOR

When adequate release of the membrane is achieved and deemed enough by the operator, an osteotomy is created in the edentulous area following the drilling sequence provided by the implant system used. the palatal packing of bone is made before the implant placement, as the palatal aspect of the sinus will be inaccessible after placement of the implant, the implant placement is done directly with the implant motor and the use of a hand driver if needed to adjust the implant platform relation to the crestal bone, followed by cover screw placement.

Procedure: Open sinus lifting with bone grafting and simultaneous implant placement

Interventions

Open sinus lifting without bone grafting and simultaneous implant placement PROCEDURE

no bone graft will be used after open sinus lifting

Open sinus lifting without bone grafting and simultaneous implant placement

Open sinus lifting with bone grafting and simultaneous implant placement PROCEDURE

bone graft will be packed palatally after open sinus elevation and before implant placement, then implant placement will took place followed by packing of bone grafts

Open sinus lifting with bone grafting and simultaneous implant placement

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Edentulous atrophic posterior maxillary ridge.
• Residual alveolar ridge height within 3-5mm.
• At least 2mm band of keratinized tissue.
• Patients with good oral hygiene.
• Compliant patients to the follow up periods.

You may not qualify if:

• Medically compromised patients.
• Smokers.
• Pregnant females.
• Patients with active periodontal disease.
• Bruxer patients.
• Patients with chronic or active sinusitis.

Sponsors & Collaborators

• Misr International University: lead

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Central Study Contacts

Ahmed I Abo El Futtouh, Dr

CONTACT

+201019999983; ahmedkey7@hotmail.com

Inas M El-Zayat, Assoc.Prof

CONTACT

+01222361579; inas.elzayat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical director of implant speciality program

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 17, 2024
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share