Irreversible PulpitisCGF Vs EndoNCT07417098
CGF Partial Pulpotomy Versus Endodontic Treatment
A study testing Other treatment in people with Irreversible Pulpitis, run by Minia University at 1 site in Egypt.
Trial summary
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Other treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2026to 25 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient-based criteria: Class ASA I or II cooperative adolescents of 11 - 17 years. Based on a 10 cm modified visual analog scale (VAS), only patients who reported a preoperative pain intensity score of ≥ 7, indicative of severe pain were included.
- Tooth-based criteria: Presence of occlusal extremely deep carious lesion with pulp exposure of mandibular first permanent molars with closed apices (i.e. class V according to Cvek's stages of root development) with sound contralateral molars to provide a reference for biomarker quantification and pulp sensibility tests. Only teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the following criteria were exclusively included:
- History of sharp, spontaneous, and lingering pain that was precipitated by thermal provocation and lasted mostly for ≥ 30 seconds.
- Early prolonged, intense, and lingering response to cold thermal stimulus and positive response electric pulp test (EPT) at low thresholds.
- Normal color and appearance of the tooth surrounding gingival tissues with no evidence of gingival inflammation, swelling, abnormal tooth mobility, or sinus tract or fistula formation upon visual and palpation inspections.
- Preoperative periapical radiograph with evidence of caries penetrating the entire thickness of the dentin with no isolating radiopaque zone separating the lesion from the pulp indicating extremely deep caries.
- Normal radiographic findings in terms of intact periodontal membrane space
Who cannot join
- Patient-based criteria: Patients with a positive history of the following conditions were excluded:
- Emotional or behavioral problems and those receiving antidepressant drugs.
- Under treatment with antibacterial or anti-inflammatory medicaments for the last four weeks (Akbal Dincer et al., 2020).
- Localized or generalized gingivitis and/or periodontitis with loss of epithelial attachment ≥ 3mm upon probing.
- Poor oral hygiene with dense accumulation of calculus or dental plaque.
- Systemic conditions such as diabetes, bleeding, immunological disorders.
Show all 10Show fewer
- Tooth-based criteria:
- Teeth with abnormal structure or developmental anomalies.
- Persistent hemorrhage from the root canal orifices lasting longer than 10 minutes.
- Loss of coronal structure beyond restorability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Pediatric and Community Dentistry Department , Faculty of Dentistry , Minia University
Minya, Minia City, 61511
Ahmad Elheeny, professor, 00201064257135, Ahmad.elheeny@mu.edu.eg
About this study
Official title: Partial Pulpotomy Usung CGF Versus Endodontic Treatment in Treating Irreversibly Inflamed Mature Peramnent Molars
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents
Read the detailed description
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents form 12-17 years old versus endodontic treatment with a 2 years follow up
- Conditions
- Irreversible Pulpitis
- Being tested
- Other treatment
- Keywords
- partial pulpotomy , CGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other treatmentProcedure or surgery
Also called partial pulpotomy using CGF
partial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents
Other treatmentProcedure or surgery
Also called Endodontic treatment using guttapercha
endodontic treatment using guttapercha in irreversibly inflamed molars in adolescents
| Study group | Role | What they receive |
|---|---|---|
| CGF partial pulpotomy | Experimental | partial pulpotomy using CGF in mature molars diagnosed with irreversible pulpitis Receives: Procedure: Other treatment |
| Endodontic treatment | Active comparator | Endodontic treatment of mature molars with irreversible pulpitits Receives: Procedure: Other treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was to compare the cumulative pain responses using modified VAS scores.
The primary outcome was to compare the cumulative pain responses using modified VAS scores which has a scale from 0 -10 after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period.
Measured: one week
Pulpal blood biomarkers
Measuring Biomarker levels via quantifying NKA, SP, IL-8, and MMP-8 in pg/ml blood after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period
Measured: one week
Secondary outcomes (3)
clinical follow up
Assess the absence of pain using VAS pain scale from 0-10
Measured: one week
clinical follow up
assess absence or presence of sensitivity to percussion using gentile taping with the back of a metal dental mirror handle.
Measured: one week
Radiographic follow up
assess the presence or absence of any signs of periapical radiolucency using parallel periapical radiographic dental x-rays using woodpecker digital sensor and its software with the Periapical Index (PAI) which has 5 scores ranging from 1-5 assessing the size of the periapical lesion after 1-, 3-, and 6-month 1 year and 2 years of follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start20 Jan 2026 (estimated)
- Primary completion20 Jan 2028 (estimated)
- Study completion25 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- 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
- Model description
- A parallel randomized controlled study that compares partial pulpotomy using CGF with endodontic treatment as a control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Kamel Mohamed abdallah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417098
- Sponsor's protocol ID
- MiniaU pedo dept
- Acronym
- CGF Vs Endo
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nawal RR, Yadav S, Duncan HF, Talwar S, Kaushik A, Singh VK, Koner BC. Discriminatory performance of the pulpal inflammatory biomarkers; Interleukin-8 and TNF-alpha in patients with symptoms indicative of reversible and irreversible pulpitis: A diagnostic accuracy study. Int Endod J. 2024 Sep;57(9):1200-1211. doi: 10.1111/iej.14078. Epub 2024 May 4.
PubMed 38703070Sabeti MA, Nikghalb K, Pakzad R, Fouad AF. The Relationship Between Pulpal Diagnostic Conditions and Potential Inflammatory Biomarkers. Int Endod J. 2026 Jan;59(1):23-37. doi: 10.1111/iej.70030. Epub 2025 Sep 9.
PubMed 40923157Karrar RN, Cushley S, Duncan HF, Lundy FT, Abushouk SA, Clarke M, El-Karim IA. Molecular biomarkers for objective assessment of symptomatic pulpitis: A systematic review and meta-analysis. Int Endod J. 2023 Oct;56(10):1160-1177. doi: 10.1111/iej.13950. Epub 2023 Jul 17.
PubMed 37392154Uesrichai N, Nirunsittirat A, Chuveera P, Srisuwan T, Sastraruji T, Chompu-Inwai P. Partial pulpotomy with two bioactive cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis: a noninferiority randomized controlled trial. Int Endod J. 2019 Jun;52(6):749-759. doi: 10.1111/iej.13071. Epub 2019 Jan 30.
PubMed 30638262
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Pulpotomy Usung CGF Versus Endodontic Treatment in Treating Irreversibly Inflamed Mature Peramnent Molars
- ClinicalTrials.gov ID
- NCT07417098
- Acronym / sponsor ID
- CGF Vs Endo / MiniaU pedo dept
- Conditions
- Irreversible Pulpitis
- Keywords
- partial pulpotomy , CGF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 25 Jan 2028 (estimated)
- First posted
- 18 Feb 2026 (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.
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents
Detailed description
partial pulpotomy of mature molars with irrevesible pulptits using CGF in adolescents form 12-17 years old versus endodontic treatment with a 2 years follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A parallel randomized controlled study that compares partial pulpotomy using CGF with endodontic treatment as a control
| Arm | Type | Receives |
|---|---|---|
| CGF partial pulpotomy | Experimental | Procedure: Other treatmentpartial pulpotomy using CGF in mature molars diagnosed with irreversible pulpitis |
| Endodontic treatment | Active comparator | Procedure: Other treatmentEndodontic treatment of mature molars with irreversible pulpitits |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patient-based criteria: Class ASA I or II cooperative adolescents of 11 - 17 years. Based on a 10 cm modified visual analog scale (VAS), only patients who reported a preoperative pain intensity score of ≥ 7, indicative of severe pain were included.
- Tooth-based criteria: Presence of occlusal extremely deep carious lesion with pulp exposure of mandibular first permanent molars with closed apices (i.e. class V according to Cvek's stages of root development) with sound contralateral molars to provide a reference for biomarker quantification and pulp sensibility tests. Only teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the teeth diagnosed with symptomatic irreversible pulpitis (SIP) were included. To validate the diagnosis of SIP, the teeth with the following criteria were exclusively included:
- History of sharp, spontaneous, and lingering pain that was precipitated by thermal provocation and lasted mostly for ≥ 30 seconds.
- Early prolonged, intense, and lingering response to cold thermal stimulus and positive response electric pulp test (EPT) at low thresholds.
- Normal color and appearance of the tooth surrounding gingival tissues with no evidence of gingival inflammation, swelling, abnormal tooth mobility, or sinus tract or fistula formation upon visual and palpation inspections.
Key exclusion criteria (10 listed)
- Patient-based criteria: Patients with a positive history of the following conditions were excluded:
- Emotional or behavioral problems and those receiving antidepressant drugs.
- Under treatment with antibacterial or anti-inflammatory medicaments for the last four weeks (Akbal Dincer et al., 2020).
- Localized or generalized gingivitis and/or periodontitis with loss of epithelial attachment ≥ 3mm upon probing.
- Poor oral hygiene with dense accumulation of calculus or dental plaque.
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 |
|---|---|---|
| Other treatmentAlso: partial pulpotomy using CGFpartial pulpotomy using CGF in irreversibly inflamed mature molars in adolescents | Procedure or surgery | CGF partial pulpotomy |
| Other treatmentAlso: Endodontic treatment using guttaperchaendodontic treatment using guttapercha in irreversibly inflamed molars in adolescents | Procedure or surgery | Endodontic treatment |
Primary outcome
The primary outcome was to compare the cumulative pain responses using modified VAS scores.
Time frame: one week
The primary outcome was to compare the cumulative pain responses using modified VAS scores which has a scale from 0 -10 after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period.
Pulpal blood biomarkers
Time frame: one week
Measuring Biomarker levels via quantifying NKA, SP, IL-8, and MMP-8 in pg/ml blood after partial pulpotomy using CGF versus Endodontic treatment throughout one week of follow-up period
3 secondary outcomes
clinical follow up
Time frame: one week
clinical follow up
Time frame: one week
Radiographic follow up
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 38703070Nawal RR, Yadav S, Duncan HF, Talwar S, Kaushik A, Singh VK, Koner BC. Discriminatory performance of the pulpal inflammatory biomarkers; Interleukin-8 and TNF-alpha in patients with symptoms indicative of reversible and irreversible pulpitis: A diagnostic accuracy study. Int Endod J. 2024 Sep;57(9):1200-1211. doi: 10.1111/iej.14078. Epub 2024 May 4.
- Background: PubMed 40923157Sabeti MA, Nikghalb K, Pakzad R, Fouad AF. The Relationship Between Pulpal Diagnostic Conditions and Potential Inflammatory Biomarkers. Int Endod J. 2026 Jan;59(1):23-37. doi: 10.1111/iej.70030. Epub 2025 Sep 9.
- Background: PubMed 37392154Karrar RN, Cushley S, Duncan HF, Lundy FT, Abushouk SA, Clarke M, El-Karim IA. Molecular biomarkers for objective assessment of symptomatic pulpitis: A systematic review and meta-analysis. Int Endod J. 2023 Oct;56(10):1160-1177. doi: 10.1111/iej.13950. Epub 2023 Jul 17.
- Results publication: PubMed 30638262Uesrichai N, Nirunsittirat A, Chuveera P, Srisuwan T, Sastraruji T, Chompu-Inwai P. Partial pulpotomy with two bioactive cements in permanent teeth of 6- to 18-year-old patients with signs and symptoms indicative of irreversible pulpitis: a noninferiority randomized controlled trial. Int Endod J. 2019 Jun;52(6):749-759. doi: 10.1111/iej.13071. Epub 2019 Jan 30.
- Individual participant dataSharing planned: Undecided
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Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Other treatment in people with Irreversible Pulpitis, run by Minia 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 18 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Kamel Mohamed, Master's degree (00201096998988, Mostafa.kamel@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was to compare the cumulative pain responses using modified VAS scores. (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417098, which also lists 4 linked publications.
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 18 Feb 2026.