Faculty of Dentistry Ainshams University
Cairo, 002, Egypt
NCT Number: NCT06693739
The goal of this clinical trial is to compare effect of different scaffolds on the regenerative potential of young permanent immature teeth with necrotic pulp. The main question it aims to answer is:
is there difference in regenerative potential using Hyaluronic acid and platelets rich fibrin as scaffolds in permanent immature teeth with necrotic pulp? participants will undergo regeneration protocol including hyaluronic acid and platelets rich fibrin as scaffolds Researchers will compare [hyaluronic acid , platelets rich fibrin , and no scaffold ] to see the regenerative potential
This study is active but is not currently recruiting participants.
Notify Me9 year–20 year
All sexes
Interventional
Not applicable
Cairo, 002, Egypt
The study will be conducted on 30 maxillary anterior teeth with open apex; with 10 maxillary anterior teeth with open apex in each group (n=10). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. single blinding will be maintained in this study as the Outcomes Assessor and the patients will not be aware of their group/used scaffold Group (I) control group with no scaffold used. Group (II) using platelets rich fibrin ( PRF) as a scaffold. Group (III) using hyaluronic acid (HYA) as a scaffold.
Procedural steps:
1st visit
1.Patients will be given anesthesia with vasoconstrictor . rubber dam isolation and access will be done 2. gentle irrigation with 1.5-3% sodium hypochlorite (NaOCl) (20ml/5 mins) using needle with closed end and side-vents with needle placed 1mm from apex will be done 3.then, irrigation will be done with saline or 17% Ethylenediaminetetraacetic acid (EDTA) (20 mL/canal, 5 min) 4. The canal space will be dried using sterile paper points 5.1ml of calcium hydroxide (metapaste) will be delivered into canal space 6.Sterile cotton pellet will be inserted and access cavity will be sealed using 3-4mm of temporary restoration (Coltosol F; Coltene Whaledent, Altstatten, Switzerland) for 3 weeks.
2nd visit
Inside each test tube three layers will be formed: a base layer containing erythrocytes, an intermediate layer of PRF clot, and a surface layer of acellular plasma. The PRF clot will be separated from the other layers and then compressed in a PRF box (Intra-Lock International).
The compressed PRF membrane will be rolled over itself to allow its implantation into the canal .
The PRF membrane will be inserted inside the root canal and condensed apically with an endodontic hand plugger.
In group (III)A sterile hand file size #50 will be used sharp strokes 2 mm beyond apex into the periapical tissue until bleeding is evident in cervical portion of canal then, hyaluronic acid hydrogel will be inserted inside the canal
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PRF membrane is placed as a scaffold inside the canal with no hyaluronic acid
hyaluronic acid gel is placed as a scaffold inside the canal with no PRF
initiate bleeding using hand files size beyond apex with sharp strokes with no PRF or hyaluronic acid placed
Time frame: 1 year
absence of pain is measured clinically by absence of pain in response to percussion and palation in relation to the related tooth
Time frame: 1 year
absence or change of periapical radiolucency is measured by standardized radiographs (paralleling technique every 3 months and cbct after 1 year)
Time frame: 1 year
using standardized radiographic assessment ( CBCT after 1 year and paralleling technique every 3 months for 1 year ) to assess
Ain Shams University
Other
Regenerative Ability of Immature Necrotic Permanent Teeth Using Different Scaffolds (A Randomized Clinical Trial)
Acronym: regeneration
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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