Irreversible PulpitisNCT06420583
Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction of Permanent First Molar
A study testing MTA pulpotomy and Extraction in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- MTA pulpotomy and Extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 8 years and 9.5 years.
- Decayed Mandibular Permanent first molars.
- Symptomatic Mandibular permanent first molar (caries-related pulpal symptoms or hypersensitivity relating to enamel hypo mineralization)
Who cannot join
- Children who are not apparently healthy.
- Lack of informed consent by the child patient's parent.
- Patients who are allergic to any of the materials used in the procedure.
- Unable to attend follow-up visits.
- Refusal of participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Cairo
Aya A AboElMagd, M.Sc, +201016794067, aya.aboelmagd@dentistry.cu.edu.eg
Passant Nagi, Ph.D, +201280557107, passant.nagi@dentistry.cu.edu.eg
About this study
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
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.
Read the detailed description
The principal investigator will carry out all treatment procedures, and the patients will be assigned.
For both interventions:
- Informed consent from participating parents.
- Baseline records photographs, percussion test, periapical and panoramic radiographs, and personal data collection.
- A diagnostic chart with personal, medical, and dental history will be filled
- Baseline Oral Health related quality of life questionnaire for each participant.
- A clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
- 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.
- 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).
- Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows:
- Administration of inferior alveolar nerve block and long buccal infiltration: Septocaine® and epinephrine 1:100,000 (Articaine HCl. 4% and Epinephrine 1:100,000 Injection) at the side of the affected tooth.
- Conditions
- Irreversible Pulpitis
- Being tested
- MTA pulpotomy, Extraction
- Keywords
- first permanent molar, pulpotomy, extraction, oral health related quality of life, post operative pain, visual analog scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA pulpotomyProcedure or surgery
Also called vital pulp therapy
- Application of rubber dam for isolation, then a standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level, bleeding control in the pulp chamber will be achieved by using 5% sodium hypochlorite.
- gentle condensation of MTA mix in the pulp chamber will be done by a wet sterile cotton pellet and then the rest of the pulp chamber will be filled with Glass Ionomer restoration.
- The tooth will be restored with a stainless steel crown.
ExtractionProcedure or surgery
After complete Anesthetic application in the affected area, non-surgical extraction will be done.
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | MTA Pulpotomy Receives: Procedure: MTA pulpotomy |
| Extraction | Active comparator | Extraction Receives: Procedure: Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
will be measured using visual analog scale (VAS) The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Measured: 24 hours post operatively
Secondary outcomes (1)
Oral health related quality of life
will be measured using Child Oral Impact on Daily Performances. It consists of 25 items distributed among 4 domains: oral symptoms, functional limitations, emotional well-being, and social well-being. It is self-reported by 8-10-year-old children using a 5-point Likert scale, and responses range from 0-4 for each item. Total scores range from 0 to100, and higher scores indicate poorer OHRQoL
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Amr Abo ElMagd, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420583
- Sponsor's protocol ID
- 2111991
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06420583
- Acronym / sponsor ID
- 2111991
- Conditions
- Irreversible Pulpitis
- Keywords
- first permanent molar, pulpotomy, extraction, oral health related quality of life, post operative pain, visual analog scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The principal investigator will carry out all treatment procedures, and the patients will be assigned.
For both interventions:
- Informed consent from participating parents.
- Baseline records photographs, percussion test, periapical and panoramic radiographs, and personal data collection.
- A diagnostic chart with personal, medical, and dental history will be filled
- Baseline Oral Health related quality of life questionnaire for each participant.
- A clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
- 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.
- 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).
- Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows:
- Administration of inferior alveolar nerve block and long buccal infiltration: Septocaine® and epinephrine 1:100,000 (Articaine HCl. 4% and Epinephrine 1:100,000 Injection) at the side of the affected tooth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: MTA pulpotomyMTA Pulpotomy |
| Extraction | Active comparator | Procedure: ExtractionExtraction |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 8 years and 9.5 years.
- Decayed Mandibular Permanent first molars.
- Symptomatic Mandibular permanent first molar (caries-related pulpal symptoms or hypersensitivity relating to enamel hypo mineralization)
Key exclusion criteria (5 listed)
- Children who are not apparently healthy.
- Lack of informed consent by the child patient's parent.
- Patients who are allergic to any of the materials used in the procedure.
- Unable to attend follow-up visits.
- Refusal of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTA pulpotomyAlso: vital pulp therapy1. Application of rubber dam for isolation, then a standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level, bleeding control in the pulp chamber will be achieved by using 5% sodium hypochlorite. 2. gentle condensation of MTA mix in the pulp chamber will be done by a wet sterile cotton pellet and then the rest of the pulp chamber will be filled with Glass Ionomer restoration. 3. The tooth will be restored with a stainless steel crown. | Procedure or surgery | Pulpotomy |
| ExtractionAfter complete Anesthetic application in the affected area, non-surgical extraction will be done. | Procedure or surgery | Extraction |
Primary outcome
Post operative pain
Time frame: 24 hours post operatively
will be measured using visual analog scale (VAS) The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
1 secondary outcome
Oral health related quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTA pulpotomy and Extraction in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 24 hours post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.