Transcrestal Lateral Sinus Floor Elevation in Implant Therapy

Edentulous; Alveolar Process, Atrophy Clinical Trial

Official title:

Trans-crestal Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail With Parallel Group Design: L-PRF Compared With DBBM

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03496038
• Other study ID #: Cortellini60096
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: June 2022

Study information

• Verified date: October 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a non-inferiority study to evaluate whether L-PRF achieves similar or perhaps better results in bone gain, compared with "the golden standard" DBBM, after trans-crestal sinus floor elevation.

Description:

This is a randomized controlled clinical trial with parallel group design. A total of 40 patients, needing transcrestal sinus lift (T), will be enrolled.

Under local anesthesia, the required T and implant placement will be performed and ISQ values will be recorded. Afterwards a CBCT will be taken for control. Randomization will be performed by computer generated random codes, using random permuted blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic factors RBH. Allocation will be concealed to the surgeons at completion of the common part of treatment, by opening an opaque envelope. At the same time an oral implant(s) will be inserted in the augmented area.

After 6 months a CBCT will be taken for control of the bone healing and the measurements of the newly formed bone. The abutment will be placed on top of the osseo-integrated implant(s) under local anesthesia. ISQ values will be recorded. Follow-up will be till 1 year.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of informed consent

• Need for T and oral implant placement.

• RBH >3mm

Exclusion Criteria:

• Unlikely to be able to comply with the study procedures, as judged by the investigator

• Untreated periodontal disease

• Unfavorable plaque control

• Known or suspected current malignancy

• History of chemotherapy within 5y prior to study

• History of radiation on the head and neck region

• History of other metabolic bone diseases

• Need for systemic corticosteroids

• Current or previous use of intravenous/oral bisphosphonates

• Present alcohol and/or drug abuse

• Involvement in the planning and conduct of the study

• Psychiatric disorders which do not allow a normal treatment outcome

Related Conditions & MeSH terms

• Atrophy
• Edentulous; Alveolar Process, Atrophy

Intervention

Procedure:
• L-PRF
The use of the L-PRF as graft material for sinus augmentation procedure will be analysed
• DBBM
The use of bovine xenograft as graft material for sinus augmentation procedure will be analysed

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Dentsply International

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric bone regeneration en volumetric change	Amount of bone formation in healing period after trans-crestal sinus floor elevation and implant placement and after healing, measured on CBCT images.; Following a healing period of 6 and 12 months a CBCT will be taken to measure the height and width of the newly formed bone and compare it to the initial CBCT. A 3-D volumetric analysis of the amount of gained bone is conducted with MeVisLab software.	6 and 12 months
Primary	Linear bone regeneration en lineair change	Amount of bone formation in healing period after trans-crestal sinus floor elevation and implant placement and after healing, measured on CBCT images.; Following a healing period of 6 and 12 months a CBCT will be taken to measure the height and width of the newly formed bone and compare it to the initial CBCT. 2-D measurement will be performed.	6 and 12 months
Secondary	Implant stability based on resonance frequency	Measurements of the implant stability via Osstell ISQ implant stability device. At implant placement and abutment connection a measurement via Osstell ISQ implant stability device will be done.	6 months