Plain English Summary
Background and study aims:
Dental implants involve inserting a screw into the jaw. When the bone has healed around the jaw and the screw is tightly held, an artificial tooth (dental prosthesis) can be attached to the screw. Where there has been bone loss, substitute bone material can be added in a separate procedure so that there is enough bone to hold the screw and prosthesis firmly. This study is investigating whether the initial bone addition to the back of the upper jaw should be allowed to heal for 3 or 6 months before the implant screw is inserted.
Who can participate?
Otherwise healthy adults who have lost teeth in the upper jaw but do not have enough bone to insert an implant screw.
What does the study involve?
The participants will be randomly allocated to one of two groups. All participants receive the same treatment, which involves the initial bone addition procedure followed later by insertion of the implant screw. One group will wait 6 months between the bone addition and implant insertion, as is currently usual. The other group will wait 3 months.
What are the possible benefits and risks of participating?
Participants will not pay for the materials used, the 6-month check-ups and oral hygiene treatments. Risks of participating are the same as for anyone undergoing this procedure, including injury or inflammation of the sinuses, infection, bleeding and implant failure.
When is the study starting and how long is it expected to run for?
July 2018 to December 2021
Who is funding the study?
Semmelweis University Doctoral School of Clinical Medicine (Hungary)
Who is the main contact?
Dr. Bálint Trimmel, balint.trimmel@dent.semmelweis-univ.hu
Trial website
Contact information
Type
Public
Primary contact
Dr Bálint Trimmel
ORCID ID
http://orcid.org/0000-0003-2308-2312
Contact details
Szentkirályi utca 47.
Budapest
1088
Hungary
+36308412533
trimmel.balint@dent.semmelweis-univ.hu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Sinus-Allo-PRF-2018-01
Study information
Scientific title
Maxillary sinus augmentation with A-RRF and serum albumin-coated allograft- prospective randomized trial for the determination of the optimal healing time for dental implant loading
Acronym
Study hypothesis
This randomized clinical study investigates the bone healing potential of advanced platelet rich fibrin (A-PRF) in combination with serum albumin-coated allograft (BoneAlbumin) after lateral sinus floor elevation.
The hypothesis of this study is that the use of A-PRF with BoneAlbumin will produce similar bone formation after 3 months of healing (test group) than the control group (6 months of healing). There will be no difference in implant stability quotient (ISQ) of the dental implants in the two treatment groups.
Ethics approval
1. Approved 18/09/2018, Office of the Chief Medical Officer of the National Public Health and Medical Service (2-6. Albert Flórián út, Budapest, H-1097 Hungary; tisztifoorvos@emmi.gov.hu; :(+36 1) 476 1100), ref: 42292-5/2018/EKU
2. Approved 18/09/2018, Scientific and Research Ethics Committee of the Health Science Council (25 Alkotmány u., Budapest, H-1054, Hungary; : (+36 1) 795 1192; attilane.gombos@emmi.gov.hu), ref: 31068-7/2018/EÜIG
Study design
Single-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Bone allografting to support dental implants
Intervention
The surgical procedure and the applied grafts for sinus augmentation from lateral approach are the same for both study arms. Grafting materials are advanced platelet rich fibrin (A-PRF) in combination with serum albumin-coated allograft (BoneAlbumin) in both treatment groups. The test and control group differ only in the graft healing period (3 vs 6 months) .
The surgical sites will randomly divide the participants into two groups by tossing a coin after the first surgical intervention is completed (sinus augmentation). Dental implants are placed 3 months (test) or 6 months (control) after bone augmentation. At the time of implant placement, bone core biopsy samples are collected directly from the implant sites with the use of a trephin bur for histological, histomorphometrical and micro-computerized tomography analysis. Histomorphometric and micro-computerized tomography analysis are performed by two investigators blinded to the treatment group. ISQ values are recorded by an Osstell device at the time of implant placement and at appointments 6, 8, 10, 12 weeks postoperatively. Prosthetic rehabilitation begins 3 months after implant placement. For follow-up, 6-month periods after final prosthesis delivery will be applied.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Percentage of newly formed bone calculated from bone biopsy samples collected from the site of dental implant placement by micro-CT and histomorphometry at 3 months (test group) and 6 months (control group) after surgery
Secondary outcome measures
1. Percentage of residual graft calculated from bone biopsies collected from the site of dental implant placement by micro-CT and histomorphometry at 3 months (test group) and 6 months (control group) after surgery
2. Percentage of connective tissue calculated from bone biopsies collected from the site of dental implant placement by micro-CT and histomorphometry at 3 months (test group) and 6 months (control group) after surgery
3. Implant stability quotient (ISQ) measured with Osstell ISQ device at implant placement and 6, 8, 10, 12 weeks after surgical intervention
Overall trial start date
27/07/2018
Overall trial end date
01/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Systemically healthy patients aged over 18 years
2. Requiring implant prostheses and oral rehabilitation
3. Insufficient residual height in posterior maxilla requiring a sinus augmentation from lateral approach to insert the implants (residual crest height ≤5 mm)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Current pregnancy or intention to become pregnant during the study follow-up period
2. Sinusitis
3. Smoking
4. Alcoholism
5. Severe haematological disorder or disease
6. History of chronic hepatitis or liver cirrhosis
7. Diabetes mellitus with poor metabolic control
8. Receiving dialysis
9. Metabolic bone disease
10. Taking bisphosphonates drugs whether orally or intravenously
11. Undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy
12. Any other inability to participate in the study
Recruitment start date
01/10/2018
Recruitment end date
30/01/2020
Locations
Countries of recruitment
Hungary
Trial participating centre
Semmelweis University,
Szentkirályi utca 47.
Budapest
1088
Hungary
Sponsor information
Organisation
Semmelweis University Doctoral School of Clinical Medicine
Sponsor details
Bókay J. u. 53. I. em.
Budapest
1083
Hungary
+36 1 324 7785
bokori.edit@med.semmelweis-univ.hu
Sponsor type
University/education
Website
http://semmelweis.hu/phd/en/doktori-iskolak-en/klinikai-orvostudomanyok-en/
Funders
Funder type
University/education
Funder name
Semmelweis Egyetem
Alternative name(s)
Semmelweis University
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Hungary
Results and Publications
Publication and dissemination plan
The results are planned to be published in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.
Intention to publish date
01/12/2022
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list