The Use of Platelet-Rich Fibrin in Partial Pulpotomy Procedure
NCT ID: NCT04331964
Last Updated: 2022-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
12 participants
INTERVENTIONAL
2020-05-01
2021-12-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Pulpotomy, Partial Pulpotomy, and Direct Pulp Capping Using Mineral Trioxide Aggregate.
NCT07333872
Evaluation of Using Platelet-Rich Fibrin in Adult Pulpotomy
NCT06437197
The Use of Portland Cement in Primary Anterior Teeth Pulpotomy.
NCT04634123
DPC in Primary Molars.
NCT05222243
Comparative Evaluation of Three Pulpotomy Agents for Permanent Mature Molars With Irreversible Pulpitis
NCT06232941
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
An essential aspect of tooth tissue engineering is the identification of a suitable scaffold to support cell growth and tissue regeneration. Platelet-Rich Fibrin (PRF) is a second generation platelet concentrate. It is strictly autologous and helps to release the growth factors necessary for the regeneration of dentin pulp complex. Therefore, PRF seems to be a suitable scaffold in vital pulp therapy.
Study sample, 24 intact maxillary or mandibular premolars which will be extracted for orthodontic reasons in 12 healthy volunteers. The sample will be chosen from the patients who are coming to the Orthodontic department in the Faculty of dentistry - Damascus university.
This study will be performed as split mouth study. For each selected patient, one premolar will be randomly allocated to MTA only and the other to combined MTA/PRF by a toss of coin. The main operator will give each patient a numerical code (from 1 to 12) whilst the teeth will have an alphabetical coding (e.g. For the patient coded as 1, premolar with MTA will be coded as 1-a, the other premolar with MTA/PRF will be coded as 1-b). In all patient documents, the teeth will be labeled in the same way so that the clinical examiner and a pathologist will be blinded to the capping technique used for each tooth whilst the main operator who perform a pulpotomy will know which technique is used for each premolar.
Postoperative pain and sensitivity to thermal stimuli will be analyzed after the treatment between two sides.
After 8 weeks, the teeth will be extracted and histologically evaluated in terms of inflammation, dentin bridge formation and its appearance.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mineral Trioxide Aggregate (MTA)
A standardized partial pulpotomy procedure will be performed after administration of local anesthesia. The exposed pulp tissues will be directly capped with a 3mm of MTA (Pro Root MTA) layer.
partial pulpotomy
Removal of a small portion of coronal pulp tissue after exposure, followed by application of a biomaterial directly onto the remaining pulp tissue prior to placement of a permanent restoration.
MTA with platelet rich fibrin (PRF).
A standardized partial pulpotomy procedure will be performed after administration of local anesthesia. The PRF membrane obtained after centrifugation of the patient's own blood is going to be placed over the exposed pulp. Then, a 3mm of MTA (Pro Root MTA) will be placed over the PRF membrane.
partial pulpotomy
Removal of a small portion of coronal pulp tissue after exposure, followed by application of a biomaterial directly onto the remaining pulp tissue prior to placement of a permanent restoration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
partial pulpotomy
Removal of a small portion of coronal pulp tissue after exposure, followed by application of a biomaterial directly onto the remaining pulp tissue prior to placement of a permanent restoration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants, with healthy first premolars in either of the jaws, assigned for orthodontic extraction (scheduled extraction of the maxillary/mandibular premolars).
3. The premolar teeth needed to be fully erupted.
4. The premolar teeth needed to respond within the normal range to cold testing and heat testing.
5. The patients' parents had read, signed and thoroughly understood the informed consent.
Exclusion Criteria
2. Anti-inflammatory medicine taken before and during the time of study.
3. Premolars with caries, restoration or any abnormality on periapical radiographs.
4. If the premolar teeth were not fully erupted.
5. If the premolar teeth revealed a lingering pain (a pain sensation that had the tendency to linger as a dull ache after the stimulus had been removed upon cold testing and heat testing).
12 Years
16 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Damascus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rami Zenaldeen, DDS MSc
Role: STUDY_DIRECTOR
PhD student at the Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic
Ossama Aljabban, DDS MSc PhD
Role: PRINCIPAL_INVESTIGATOR
Professor at Endodontic and Operative Dentistry Department, University of Damascus Dental School, Damascus, Syrian Arab Republic
Mohammad Y Hajeer, DDS MSc PhD
Role: STUDY_DIRECTOR
Associate Professor at Department of Orthodontics, University of Damascus Dental School, Damascus, Syrian Arab Republic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Endodontics and Operative Dentistry, University of Damascus Dental School, Damascus, Syria
Damascus, , Syria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Azimi S, Fazlyab M, Sadri D, Saghiri MA, Khosravanifard B, Asgary S. Comparison of pulp response to mineral trioxide aggregate and a bioceramic paste in partial pulpotomy of sound human premolars: a randomized controlled trial. Int Endod J. 2014 Sep;47(9):873-81. doi: 10.1111/iej.12231. Epub 2014 Jan 13.
Bakhtiar H, Nekoofar MH, Aminishakib P, Abedi F, Naghi Moosavi F, Esnaashari E, Azizi A, Esmailian S, Ellini MR, Mesgarzadeh V, Sezavar M, About I. Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial. J Endod. 2017 Nov;43(11):1786-1791. doi: 10.1016/j.joen.2017.06.025. Epub 2017 Aug 16.
Chailertvanitkul P, Paphangkorakit J, Sooksantisakoonchai N, Pumas N, Pairojamornyoot W, Leela-Apiradee N, Abbott PV. Randomized control trial comparing calcium hydroxide and mineral trioxide aggregate for partial pulpotomies in cariously exposed pulps of permanent molars. Int Endod J. 2014 Sep;47(9):835-42. doi: 10.1111/iej.12225. Epub 2014 Jan 28.
Hiremath H, Saikalyan S, Kulkarni SS, Hiremath V. Second-generation platelet concentrate (PRF) as a pulpotomy medicament in a permanent molar with pulpitis: a case report. Int Endod J. 2012 Jan;45(1):105-12. doi: 10.1111/j.1365-2591.2011.01973.x. Epub 2011 Nov 14.
Mehrvarzfar P, Abbott PV, Mashhadiabbas F, Vatanpour M, Tour Savadkouhi S. Clinical and histological responses of human dental pulp to MTA and combined MTA/treated dentin matrix in partial pulpotomy. Aust Endod J. 2018 Apr;44(1):46-53. doi: 10.1111/aej.12217. Epub 2017 Aug 18.
Solomon RV, Faizuddin U, Karunakar P, Deepthi Sarvani G, Sree Soumya S. Coronal Pulpotomy Technique Analysis as an Alternative to Pulpectomy for Preserving the Tooth Vitality, in the Context of Tissue Regeneration: A Correlated Clinical Study across 4 Adult Permanent Molars. Case Rep Dent. 2015;2015:916060. doi: 10.1155/2015/916060. Epub 2015 May 17.
Woo SM, Kim WJ, Lim HS, Choi NK, Kim SH, Kim SM, Jung JY. Combination of Mineral Trioxide Aggregate and Platelet-rich Fibrin Promotes the Odontoblastic Differentiation and Mineralization of Human Dental Pulp Cells via BMP/Smad Signaling Pathway. J Endod. 2016 Jan;42(1):82-8. doi: 10.1016/j.joen.2015.06.019. Epub 2015 Sep 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UDDS-OperDent-01-2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.