A Standardized Novel Periapical Radiography Technique for Long Term Follow up of Implants Inserted Simultaneously With Sinus Allogenic Bone Augmentation

NCT06773637 | Completed

• 1 other identifier: 2024/842
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The Aim of this study is introducing a standardized novel periapical radiography technique for long term follow up of implants inserted simultaneously with sinus allogenic bone augmentation. This novel standardized periapical radiographic technique was introduced and has been performed on patients who were already enrolled in a study performed at Suez Canal University. This aforementioned study was conducted in fulfillment of a PHD thesis that had the ethical approval number of 419/2021. In that study according to its sample size calculation, 30 implants were tested for a long term, 1 year follow up after having undergone open or closed sinus elevation as a surgical procedure (according to the random sequence generated at that time). In addition to simultaneous implant placement and allogenic bone grafting. Hence for the purpose of accurate measurement of mesial and distal marginal bone changes for these implants over the different follow up intervals and up to one year after implant placement a standardized jig had to be created. This jig had to be customized for each patient and had to maintain its shape and integrity and patient position every time a periapical radiograph was performed. These patients were followed up using this radiographic technique immediate postoperatively, 3, 9 and 12 months postoperatively to evaluate the mesial and distal marginal bone levels according to the previously mentioned study protocol.

Conditions

Open Sinus Elevation; Periapical Radiograph

Keywords

periapical radiograph; dental implants; open sinus elevation; closed sinus elevation

Outcome Measures

Primary Outcomes (1)

• Mesial and Distal Marginal bone level:

  Marginal bone level was measured at T1, T2, T3 and T4 follow up periods, by using a standardized periapical radiograph using paralleling device film holders and a customized occlusal jig to hold a PSP digital x ray film as was explained before. The mesial and distal marginal bone levels were recorded at each of the follow up periods by measuring the length on the CLINIVIEWTM software between the implant platform and the highest visible bone level at the mesial and distal levels of the implant.

  1 year

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This novel standardized periapical radiographic technique was introduced and has been performed on patients who were already enrolled in a study performed at Suez Canal University. This aforementioned study was conducted in fulfillment of a PHD thesis that had the ethical approval number of 419/2021. In that study according to its sample size calculation, 30 implants were tested for a long term, 1 year follow up after having undergone open or closed sinus elevation as a surgical procedure (according to the random sequence generated at that time). In addition to simultaneous implant placement and allogenic bone grafting. Hence for the purpose of accurate measurement of mesial and distal marginal bone changes for these implants over the different follow up intervals and up to one year after implant placement a standardized jig had to be created. This jig had to be customized for each patient and had to maintain its shape and integrity and patient position every time a periapical

You may qualify if:

• \. Males and females ≥ 18 years of age. 2. ASA I and ASA II. 3. Patients having partial edentulism in the posterior region of the maxilla. 4. Edentulous sites consist of native non augmented bone. 5. Horizontal ridge dimension minimum of 5mm 6. The vertical ridge dimension 4-7 mm. 7. Bone quality of D2 or D3. 8. Enough inter-arch distance. 9. The presence of one-year postoperative radiograph CBCT. 10. Presence of postoperative follow up clinical data.

You may not qualify if:

• \. Patients with active acute infection or residual lesion related to the edentulous sites. 2. Acute maxillary sinus pathosis 3. A remaining root dislodged in the Maxillary sinus. 4. Patients that lack a stable occlusion or have parafunctional habits. 5. Patients with poor oral hygiene who are not amenable to motivation and improvement. 6. Smokers who smoke more than 10 cigarettes a day. 7. Pregnant or lactating mothers. 8. Alcohol and drug abuse. 9. Treatment with radiation therapy in the craniofacial region within the previous 12 months

Sponsors & Collaborators

• Misr International University: lead
• Suez Canal University: collaborator

Study Sites (1)

Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Suez Canal University

Ismailia, 41522, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer Oral & Maxillofacial Surgery Department

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: June 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

EG (1)