Assessment Crestal Maxillary Sinus Membrane Elevation Using Different Implant Heights

Radiographic Assessment of Crestal Maxillary Sinus Membrane Elevation Using Different Dental Implant Heights in Atrophic Posterior Maxilla

This study is aiming to evaluate primary stability and bone gain in trans-crestal osseodencification technique using Regular concaved osteotomes at different height elevations.

Study Overview

• Status: Recruiting
• Conditions: Bone Formation Around Implant After Crestal Sinus Lifting
• Intervention / Treatment: Procedure: trans-crestal sinus lifting

Detailed Description

For those patient who need up to 2-6 mm of vertical height, the 1-stage transcrestal osteotome technique shown to be stable over long term.

The most important negative factor that can be inferred from the results is that BAOSFE becomes less predictable when there is 4 mm or less of preexisting alveolar bone height beneath the sinus. Moreover, more challenging situation is the magnitude of tapping force, which may accidently perforate the antral membrane causing a lot of complication in the naso-antral apparatus by excessive taping force. The expansion of the osteotomy sites is performed with a number of Concave tipped tapered osteotomes with increasing diameters that are applied through the edentulous alveolar crest at the inferior border of the maxillary sinus floor. With each insertion of a larger osteotome, bone is compressed, pushed laterally and apically while pushing the garnered bone apically beneath the tented membrane.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Maher mohammad Maqbol, BDS; Phone Number: 0020 01141722802; Email: maher.maqbol@dentistry.cu.edu

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 11553
      • Recruiting
      • Maher Mohammed Hebah Maqbol
      • Contact: Mohammad m Khashaba, PHD; Phone Number: 0020 01227754765; Email: mohammedkhashaba@hotmail.com
      • Sub-Investigator: Mohammad m Atef, PHD
      • Principal Investigator: Mohammad m Khashaba
      • Sub-Investigator: Maher m Maqbol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with edentulous vertically deficient posterior maxillary ridge a minimum 4 mm height of alveolar bone, and 6 mm in width.
• Both males as well as females without any active periodontal disease.
• All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
• All selected patients are non-smokers and non-alcoholics.
• Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
• The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
• Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

1. On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
2. General contraindications to implant surgery.
3. Subjected to irradiation in the head and neck area less than 1 year before implantation.
4. Untreated periodontitis.
5. Poor oral hygiene and motivation.
6. Uncontrolled diabetes.
7. Pregnant or nursing.
8. Substance abuse.
9. Psychiatric problems or unrealistic expectations.
10. Severe bruxism or clenching.
11. Immunosuppressed or immunocompromised.
12. Treated or under treatment with intravenous amino-bisphosphonates.
13. Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
14. Active infection or severe inflammation in the area intended for implant placement.
15. Need of bone augmentation procedures at implant placement.
16. Unable to open mouth sufficiently to accommodate the surgical tooling.
17. Patients participating in other studies, if the present protocol could not be properly followed.
18. Referred only for implant placement or unable to attend a 5-year follow-up.
19. Requiring only single implant-supported crowns.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: bone formation around implant at 2mm membrane elevation crestal sinus lifting	Procedure: trans-crestal sinus lifting; this study will be divided in to three different groups, each group will receive a same technique of Crestal maxillary sinus lifting and implant placement at 2,4,6 mm heights.; Other Names: Closed sinus lifting
ACTIVE_COMPARATOR: bone formation around implant at 4mm membrane elevation crestal sinus lifting	Procedure: trans-crestal sinus lifting; this study will be divided in to three different groups, each group will receive a same technique of Crestal maxillary sinus lifting and implant placement at 2,4,6 mm heights.; Other Names: Closed sinus lifting
ACTIVE_COMPARATOR: bone formation around implant at 6mm membrane elevation crestal sinus lifting	Procedure: trans-crestal sinus lifting; this study will be divided in to three different groups, each group will receive a same technique of Crestal maxillary sinus lifting and implant placement at 2,4,6 mm heights.; Other Names: Closed sinus lifting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring bone formation and density beyond apical part of dental implant after closed sinus lifting	CBCT superimposition of the Pre-operative and Post-operative	4 months after Dental implant placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring secondary stability of dental implants	osttell device (ISQ)	4 months after Dental implant placement

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ACTUAL): December 20, 2021
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (ACTUAL): December 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Stability, implant. sinus lifting, bone formation
• Other Study ID Numbers: o m f s 335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes