Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03631511
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2018-07-24
Brief Title:
Histological Evaluation of Hard Tissue Formation After Direct Pulp Capping With RetroMTA
Sponsor:
Pomeranian Medical University Szczecin
Organization:
Pomeranian Medical University Szczecin
Study Overview
Official Title:
Histological Evaluation of Direct Pulp Capping on Human Pulp Tissue Using a RetroMTA
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RetroMTA
Brief Summary:
This study presents a clinical and histological evaluation of human pulp tissue responses after direct capping using RetroMTA Seven teeth were subjected to pulp exposure direct capping with RetroMTA and restoration with a composite resin Seven months later the teeth were clinically and radiographically evaluated The teeth were then extracted and subjected to histological processing and evaluation
Detailed Description:
The study was conducted in accordance with the tenets of the World Medical Association Declaration of Helsinki Seven caries-free intact maxillary and mandibular third molars from humans aged 30-37 years which were scheduled for extraction for orthodontic or surgical purposes were included in the study The patients received a thorough explanation of the experimental rationale clinical procedures and possible complications All experimental protocols were independently reviewed and approved by the Local Ethics Committee of Pomeranian Medical University Szczecin Poland approval number KB-00122713
Clinical protocol For all included teeth periapical radiographs were taken to exclude the presence of caries or periapical pathology Tooth sensitivity was assessed by thermal testing Kältespray MW Dental Büdingen Germany and electric sensitivity testing Vitality Scanner Pulp Vitality Tester SybronEndo Orange CA USA These teeth were subjected to pulp exposure direct capping with RetroMTA and restoration with a composite resin Seven months later the teeth were clinically and radiographically evaluated Clinical assessment was performed at 1 week and at 7 months after the procedure During clinical interviews the patients were asked about the presence of pain and its type and duration Reactions to thermal stimuli were classified into three categories 1 normal response pain lasting up to 10 s 2 an extended response pain 10 s 3 no response An electrical test was performed using a Vitality Scanner and was repeated three times Seven months after the procedure the teeth were extracted and subjected to histological processing and evaluation
Histological processing Immediately after extraction the teeth were immersed in a 10 neutral buffered formalin solution and gently washed from blood and saliva After brief prefixation 10 minutes special precautions were taken to facilitate pulp tissue fixation The roots were separated 5 mm apically to the cemento-enamel junction using a diamond disk under copious water cooling Then the teeth were grinded with a high speed cylindrical diamond bur under water spray in a mesio-distal or bucco-lingual plane until exposing one or more pulp horns Photographs and radiographs were taken of each sample before successive steps For demineralization the specimens were immersed for 3 to 4 weeks in an aqueous solution consisting of a mixture of 225 vv formic acid and 10 wv sodium citrate with radiographic determination of the end-point Then all specimens were washed in running tap water for 24 hours dehydrated using ascending grades of ethanol cleared in xylene infiltrated and embedded in paraffin melting point of 56 C following standard procedures The paraffin blocks were trimmed With the microtome set at 5 μM serial sections were taken until exhausting the entire pulp tissue in the chamber Six to eight sections were collected on each slide Every fifth slide was stained with haematoxylin and eosin for screening and evaluation of mineralized tissue formation These stained sections were used to locate the areas exhibiting the most severe inflammatory reactions and those with less favourable bridging Based on this initial evaluation all slides adjacent to the location with the less favourable conditions were stained In addition the selected slides were subjected to a modified Brown and Brenn technique Taylor 1966 for staining bacteria Next cover slips were placed on the slides and the sections were examined using a light microscope For each pulp the worst histologic condition observed was recorded If bacteria were observed on the cavity walls or in the area of exposure the case was excluded from evaluation
Two intact teeth one maxillary and one mandibular third molar extracted for pericoronitis were used as control To test the reliability of the bacterial stain two teeth with deep caries were examined extracted because deemed non-restorable These teeth were processed using the same protocol as the experimental group
Slides were observed under a light microscope Leica DMLB Leica Microsystems Wetzlar Germany and digital photographs were taken Leica DFC420 Leica Microsystems Wetzlar Germany Following aspects were observed with particular care 1 Presence and type of mineralized tissues formed in the area of the surgical exposure 2 Morphology of cells layering this mineralized tissue 3 Presence and degree of inflammatory reactions in the pulpal area subjacent to the newly formed tissue and 4 Presence of stainable bacteria in the experimental cavity or the area of pulp exposure
Clinical protocol For all included teeth periapical radiographs were taken to exclude the presence of caries or periapical pathology Tooth sensitivity was assessed by thermal testing Kältespray MW Dental Büdingen Germany and electric sensitivity testing Vitality Scanner Pulp Vitality Tester SybronEndo Orange CA USA These teeth were subjected to pulp exposure direct capping with RetroMTA and restoration with a composite resin Seven months later the teeth were clinically and radiographically evaluated Clinical assessment was performed at 1 week and at 7 months after the procedure During clinical interviews the patients were asked about the presence of pain and its type and duration Reactions to thermal stimuli were classified into three categories 1 normal response pain lasting up to 10 s 2 an extended response pain 10 s 3 no response An electrical test was performed using a Vitality Scanner and was repeated three times Seven months after the procedure the teeth were extracted and subjected to histological processing and evaluation
Histological processing Immediately after extraction the teeth were immersed in a 10 neutral buffered formalin solution and gently washed from blood and saliva After brief prefixation 10 minutes special precautions were taken to facilitate pulp tissue fixation The roots were separated 5 mm apically to the cemento-enamel junction using a diamond disk under copious water cooling Then the teeth were grinded with a high speed cylindrical diamond bur under water spray in a mesio-distal or bucco-lingual plane until exposing one or more pulp horns Photographs and radiographs were taken of each sample before successive steps For demineralization the specimens were immersed for 3 to 4 weeks in an aqueous solution consisting of a mixture of 225 vv formic acid and 10 wv sodium citrate with radiographic determination of the end-point Then all specimens were washed in running tap water for 24 hours dehydrated using ascending grades of ethanol cleared in xylene infiltrated and embedded in paraffin melting point of 56 C following standard procedures The paraffin blocks were trimmed With the microtome set at 5 μM serial sections were taken until exhausting the entire pulp tissue in the chamber Six to eight sections were collected on each slide Every fifth slide was stained with haematoxylin and eosin for screening and evaluation of mineralized tissue formation These stained sections were used to locate the areas exhibiting the most severe inflammatory reactions and those with less favourable bridging Based on this initial evaluation all slides adjacent to the location with the less favourable conditions were stained In addition the selected slides were subjected to a modified Brown and Brenn technique Taylor 1966 for staining bacteria Next cover slips were placed on the slides and the sections were examined using a light microscope For each pulp the worst histologic condition observed was recorded If bacteria were observed on the cavity walls or in the area of exposure the case was excluded from evaluation
Two intact teeth one maxillary and one mandibular third molar extracted for pericoronitis were used as control To test the reliability of the bacterial stain two teeth with deep caries were examined extracted because deemed non-restorable These teeth were processed using the same protocol as the experimental group
Slides were observed under a light microscope Leica DMLB Leica Microsystems Wetzlar Germany and digital photographs were taken Leica DFC420 Leica Microsystems Wetzlar Germany Following aspects were observed with particular care 1 Presence and type of mineralized tissues formed in the area of the surgical exposure 2 Morphology of cells layering this mineralized tissue 3 Presence and degree of inflammatory reactions in the pulpal area subjacent to the newly formed tissue and 4 Presence of stainable bacteria in the experimental cavity or the area of pulp exposure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None