Condition category
Oral Health
Date applied
14/10/2019
Date assigned
16/10/2019
Last edited
16/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

16/10/2019: Trial's existence confirmed by the Office of the Chief Medical Officer of The National Public Health and Medical Officer Service, Hungary.