Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06190860 |
| Other study ID # |
1181007 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2022 |
| Est. completion date |
March 31, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Universidad de los Andes, Chile |
| Contact |
Constanza Martínez, DDS PhD |
| Phone |
56987660640 |
| Email |
cemartinezc[@]uandes.cl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Bone healing is affected by smoking, particularly healing of extraction sockets, showing
deficiencies in vertical and horizontal bone dimensions compared to the healing of
non-smokers. Several approaches have been made to stimulate.
Bone wound healing, including human autologous blood-derived fractions. One of these
fractions is the leukocyte platelet-rich fibrin (L-PRF).
L-PRF has been evidenced as potentially beneficial in promoting bone defect filling in
alveolar bone and socket preservation in non-smokers. However, scarce evidence is related to
this beneficial effect in smokers.
This clinical trial aims to study and compare the in vivo effects of L-PRF during bone wound
healing and regeneration in smokers.
The main question is:
Has the L-PRF a beneficial effect during alveolar ridge preservation in smokers? After
consent, participants with tooth extraction indications and implant rehabilitation treatment
will be enrolled. After randomization, participants will be assigned to an experimental group
treated with L-PRF plugs and membranes or a control group (physiological healing).
Participants will receive two interventions:
- First intervention: Tooth extraction, intraoral scan, and Cone Beam Computed Tomography
in the treated zone.
- Second intervention (4 months after first intervention): intraoral scan and Cone Beam
Computed Tomography in the treated zone
Description:
- This study will be conducted according to the principles outlined in the Declaration of
Helsinki regarding experiments on human beings. This work was submitted and approved by
the Ethics and Scientific Committee, approval number ID170706007.
- Participant selection: Volunteers must agree to participate in the study after signing
an informed consent (previously approved by the Ethics Committee). Participants will be
treated at the Dental Clinical School of Dentistry at the Pontificia Universidad
Católica de Chile or in the Dentistry/ Health Sciences Center at San Bernardo from the
University of the Andes, Chile. Both institutions are located in Santiago, Chile.
Diagnosis and evaluation before interventions: Volunteer participants will be selected after
a clinical and periapical radiographic examination to establish the need for tooth
extraction. Laboratory tests, including a complete blood coagulation profile, will be
required for all volunteers. Finally, a salivary cotinine test will ensure the smoker's
condition.
- Randomization: A random number will be assigned to all participants. An independent
research team member will establish a randomization sequence without contact with the
clinician's team. Sealed envelopes with randomization will be performed and opened by
surgeons before the tooth extraction.
- First Intervention: Participants assigned to the experimental group will be treated with
L-PRF plugs and membranes from venous blood. Participants will have drawn blood after
venipuncture (median cubital vein) into sterile, glass-coated plastic 9 mL tubes without
anticoagulant. These tubes will be centrifuged at 2700 rpm for 12 min (Relative
Centrifugal Forces-clot = 408 g). After tooth extraction, participants in the
experimental group will be treated with L-PRF plugs and membranes, and the control group
will be sutured. Participants in both groups will be intraoral scan and intraoral scan
and Cone Beam Computed Tomography in the treated zone. Clinicians will make a
post-surgical control to evaluate how healing will be performed.
- Second Intervention: Four months after the first Intervention, participants will recall
getting a second scan and Cone Beam Computed Tomography in the treated zone. Images will
be used for implant treatment planification. Before implant placement, a biopsy (2 mm in
diameter) will be taken. The biopsy will be analyzed by Micro-computed tomography and
decalcified and included in paraffin for histological sections.
- The primary outcome variable established will be radiographic linear changes in
horizontal width and vertical height of the alveolar ridge measured in the CBCTs taken
immediately after tooth extraction and after four months. Secondary outcomes included
the changes in ridge contours and volume estimated from the intraoral scan images.
- Data analysis: Members of the research team who do not know the group intervention of
the participants will determine alveolar ridge height and width in oral scans and CBCTs
taken in the first and second Interventions. As such, micro-CT analysis and histological
sections will be analyzed.
- Statistical analysis The results will express the mean ± 95% CI. Will be considered as
significant differences when P < 0.05. Nominal data will be evaluated.
