Prospective Study of Bone Augmentation With Lateral Sinus Lift and Osseointegration of Dental Implants

NCT07014085 | Not Yet Recruiting DMC

• 1 other identifier: Oral surgery and Oral medicine
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

By using a split-mouth model in the maxilla, lateral sinus lift procedures will be performed using xenograft on one side vs autologous bone augmentation and PRF membranes on the other side. The purpose is to qualify and verify each step of this study to ensure the reliability and validity of the results.

Conditions

Atrophic Maxilla; Partial Edentulism

Keywords

bone augmentation; dento alveolar surgery; oral surgery; comparative prospective study; clinical study; lateral sinus lift; dental implants; osseointegration; prf; autologus graft; xenograft; atrophic maxilla

Outcome Measures

Primary Outcomes (2)

• Effect of autogenous bone graft vs xenograft

  Quality measurements of bone augmentation with autologous and xenograft with histology and radiological examination

  Up to two years

• Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts Dental Implant Patients: A Comparative Clinical Study

  Measurement of survival rates and osseointegration of dental implants with questionnaires and radiology examination

  Up til 2 years

Secondary Outcomes (1)

• A prospective clinical study 3 years of follow up: Bone graft with dental implants

  Up to 3 years

Study Arms (1)

5 years follow up study

OTHER

osseointegration 5 year follow up

Procedure: "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study

Interventions

"Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study PROCEDURE

Split mouth comparative clinical prospective study xenograft vs autologous graft

5 years follow up study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partially edentulous jaws in the lateral segment with 2 or more nearby lost teeth in the posterior upper jaw (maxilla), where the vertical height is a minimum of 2mm
• absence of marginal periodontal disease
• patients in American Society of Anesthesiologists ASA group 1-2 over 18 years.

You may not qualify if:

• ASA group 3 and above
• ongoing infection
• bruxism or abnormal habit
• poor oral hygiene
• medical conditions that may compromise healing (uncontrolled diabetes etc)
• treatments that interfere with healing in the jaw bone (bisphosphonate, steroid therapy) radiotherapy or chemotherapy within the last 5 years
• alcohol or substance abuse
• heavy smoking
• pregnancy
• desire not to participate

Sponsors & Collaborators

• Maria H. Pham: lead

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Central Study Contacts

Maria H Pham, DDS, PhD

CONTACT

+4740044139; hmnpham@uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor, oral surgeon, DDS, PhD

Model Details: split mouth, using the participant as a control vs test group

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share