This is a parallel arm, randomised control clinical Trial (RCT) on a cohort of Dublin
Dental University Hospital patients who are having dental implants placed in the maxilla
or mandible.
Study sample:
Subjects will be recruited from a population of patients who have been referred to
Dublin University Dental Hospital from general practice or specialist practice for
provision of implants
Subjects will be recruited from a population of patients who have been referred from
another department within the Dublin Dental Hospital for provision of implants.
Enrolment and Consent:
Participants will be selected via two methods:
Subjects will be recruited from a population of patients who have been referred to
Dublin University Dental Hospital from general practice or specialist practice for
provision of implants.
Subjects will be recruited from a population of patients who have been referred from
another department within the Dublin Dental University Hospital for provision of
implants. Patients being referred for implants to the Dublin Dental University
hospital initially attend a dental implant assessment appointment. If at that
appointment they are deemed suitable to be enrolled in the study, a gatekeeper, Ms
Niamh Leonard, will invite the patient to take part in the research study. (Please
note that Ms Niamh Leonard is an experienced gatekeeper and an administrator in the
Division of Restorative Dentistry and Periodontology in the Dublin Dental Hospital,
but is not involved in study patient's care. She will only be involved in inviting
patients to take part in the study). Patients will have an opportunity to discuss
the study in detail and will be provided with a written copy of the Patient
Information Leaflet (PIL) to take home. For any question that may arise regarding
the research or the surgical procedure patients will be able to contact the
co-investigator (Dr Rawan Kahatab) as the contact details appear on the information
leaflet. Patients will be given time (at least 7 days) to consider their
participation and can contact the gatekeeper if they opt to participate. Patients
will sign a freely given informed consent form prior to their enrolment in the
study.
If a single patient will be receiving more than one dental implants and there are
numerous implant sites that qualify for entry into the research, only one of the implant
sites will be randomly selected for the study. If a patient opts not to participate, it
will not affect their care.
Randomisation:
At the time of surgery, each patient will select a numbered, sealed envelope with the
treatment group allocation. Each envelope will correspond to a number on a
computer-generated randomisation list created prior to enrolment of study participants.
The operator will then use either the H-PRF or not use H-PRF when placing the implant
depending on what was revealed when the envelope was opened. Neither the operator or the
patient can be blinded to the arm chosen as blood sample will only be taken for the H-PRF
group.
The blood sample collection and surgeries will be performed by Dr Rawan Kahatab.
H-PRF is used regularly in the DDUH and the clinical protocol will not deviate from
standard procedures used at the hospital. H-PRF preparation protocol involves taking a
sample of venous blood from patients using a butterfly needle to collect up to 8-9ml
tubes of blood. After the first tube is collected, it would immediately be placed in a
horizontal centrifuge machine, balanced out with 3 tubes of water, to ensure the
centrifuge is properly balanced. A set rpm and time will be chosen, and the centrifuge
will run until the time is complete. The H-PRF clots would then be ready and taken out of
the tubes to separate them from the red blood cells. Peri-apical radiographs of the
surgical site are taken pre-operatively, at implant placement and at implant restoration
for all implants placed at the Dublin Dental University Hospital.
Similar studies that have previously been carried out to assess the effect of PRF on
implant stability have focused on PRF produced from fixed-angle systems as opposed to
horizontal ones. However, they have followed a very similar design to our proposed
design. For example, in a study by Tabrizi et al., (2017), a split-mouth randomised
clinical trial was performed. Twenty patients with missing teeth in the molar region of
the maxilla, requiring bilateral implants, were included. PRF was used on one side (group
1); no PRF was used on the other (group 2). Implant stability was assessed by resonance
frequency analysis (RFA) at 2, 4, and 6 weeks after placement. At 2 weeks, the mean ISQ
was 60.60 ± 3.42 in group 1 and 58.25 ± 3.64 in group 2; at 4 weeks it was 70.30 ± 3.36
in group 1 and 67.15 ± 4.33 in group 2; at 6 weeks it was 78.45 ± 3.36 in group 1 and
76.15 ± 2.94 in group 2. Significant differences in RFA were found between the groups at
2 weeks (P = 0.04), 4 weeks (P = 0.014), and 6 weeks (P = 0.027) after placement.
The study results suggest that the use of PRF may enhance the post-insertion stability of
dental implants placed in the posterior maxilla during the healing period. In another
study by Oncu et al., (2015), twenty healthy patients with adequate alveolar bone and two
or more adjacent missing teeth extracted at least 6 months previously were included. A
minimum of two tapered implants were placed in each patient. After surgical preparation
of the implant sockets, PRF that had been prepared preoperatively was placed randomly
into one of the sockets. Resonance frequency measurements were made after implant
placement and at 1 week and 1 month postoperatively. Mean implant stability quotients
(ISQs) of the PRF implants was 69.3 ± 10.5, and mean ISQs for the PRF- implants was 64.5
± 12.2 at the end of the first week. The mean ISQs at 4 weeks postoperatively were 77.1 ±
7.1 for the PRF+ group and 70.5 ± 7.7 for the group without PRF. In this study, PRF
application increased implant stability during the early healing period, as evidenced by
higher ISQ values. Based on the results of these studies and the fact that H-PRF is an
even more superior biomaterial than PRF, our study should achieve outcomes that are just
as successful.