Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420583
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-10
Brief Title:
Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction of Permanent First Molar
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction for the Management of Permanent First Molar With Poor Prognosis A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of this clinical trial is to compare between post operative pain and oral health related quality of life in participants receiving two treatments for first permanent mandibular molars with poor prognosis
Group I Experimental group Complete Pulpotomy with the use of MTA followed by stainless steel crown
Group II Control group Non-surgical extraction
Group I Experimental group Complete Pulpotomy with the use of MTA followed by stainless steel crown
Group II Control group Non-surgical extraction
Detailed Description:
The principal investigator will carry out all treatment procedures and the patients will be assigned
For both interventions
1 Informed consent from participating parents
2 Baseline records photographs percussion test periapical and panoramic radiographs and personal data collection
3 A diagnostic chart with personal medical and dental history will be filled
4 Baseline Oral Health related quality of life questionnaire for each participant
5 A clinical examination will be performed to assess the clinical inclusion criteria Pulpal and periapical diagnoses are established after clinical examination
6 Preoperative and Postoperative photographs will be taken
7 The radiographic examination will be performed by taking a periapical radiograph and a Panoramic radiograph through a machine to assess the inclusion criteria The preoperative radiograph will serve as a reference for the follow-up radiographs Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using an X-ray holding device
8 Preoperative and postoperative radiographs in the pulp therapy group will be taken by a parallel technique using an XCP film holder Super Bite Hawe Neos DentalSA Switzerland
9 Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows
10 Administration of inferior alveolar nerve block and long buccal infiltration Septocaine and epinephrine 1100000 Articaine HCl 4 and Epinephrine 1100000 Injection at the side of the affected tooth
For both interventions
1 Informed consent from participating parents
2 Baseline records photographs percussion test periapical and panoramic radiographs and personal data collection
3 A diagnostic chart with personal medical and dental history will be filled
4 Baseline Oral Health related quality of life questionnaire for each participant
5 A clinical examination will be performed to assess the clinical inclusion criteria Pulpal and periapical diagnoses are established after clinical examination
6 Preoperative and Postoperative photographs will be taken
7 The radiographic examination will be performed by taking a periapical radiograph and a Panoramic radiograph through a machine to assess the inclusion criteria The preoperative radiograph will serve as a reference for the follow-up radiographs Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using an X-ray holding device
8 Preoperative and postoperative radiographs in the pulp therapy group will be taken by a parallel technique using an XCP film holder Super Bite Hawe Neos DentalSA Switzerland
9 Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows
10 Administration of inferior alveolar nerve block and long buccal infiltration Septocaine and epinephrine 1100000 Articaine HCl 4 and Epinephrine 1100000 Injection at the side of the affected tooth
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