Growth HormoneNCT06433375
Evaluation of the Efficacy of Growth Hormone, EndoSeal MTA Sealer, and Their Combination on Healing of Periapical Pathosis
A study testing Growth hormone application and Root canal treatment in people with Growth Hormone and EndoSeal MTA, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of growth hormone, EndoSeal MTA sealer, and their combination on Healing of Periapical Pathosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone, EndoSeal MTA, Periapical Pathosis
- What is being tested?
- Growth hormone application and Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Apr 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Necrotic teeth with related periapical swelling or sinus tract.
- Teeth with previous root canal fillings and /or indirect coronal restoration.
- Teeth with abnormal root canal anatomy.
- Non-restorable teeth due to insufficient coronal tooth structure.
- Teeth with periodontal disease.
- Teeth with grade III mobility.
- Teeth with clinical evidence of a missing buccal bony plate over the periapical defect.
- Traumatized teeth with suspected root cracks, fractures, intrusive and extrusive injuries, previously avulsed or lateral luxation injuries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Growth Hormone, EndoSeal MTA Sealer, and Their Combination on Healing of Periapical Pathosis(Non-Surgical Approach)
This study aimed to evaluate the effect of growth hormone, EndoSeal MTA sealer, and their combination on Healing of Periapical Pathosis.
Read the detailed description
Out of 100 healthy male patients aged 18 to 40 years, 32 were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores 1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Single-rooted permanent teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.
- Conditions
- Growth Hormone, EndoSeal MTA, Periapical Pathosis
- Being tested
- Growth hormone application, Root canal treatment
- Keywords
- Periapical Pathosis, Growth Hormone, EndoSeal MTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormone applicationProcedure or surgery
Growth hormone application during non-surgical root canal treatment
Root canal treatmentProcedure or surgery
Teeth undergo conventional root canal treatment without any additional intervention
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone group | Experimental | Teeth undergo Growth Hormone application before obturation using EndoSeal MTA sealer Receives: Procedure: Growth hormone application |
| Control group | Experimental | Teeth undergo conventional root canal obturation using EndoSeal MTA sealer without any additional intervention Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative CBCT scan
Evaluation of non surgical root canal tratment healing according to CBCTPAI
Measured: 6 months
Post operative CBCT scan
Evaluation of non surgical root canal tratment healing according to CBCTPAI
Measured: 12 months
Secondary outcomes (5)
Post operative pain assesment
The postoperative pain assessment was done after obturation, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
Measured: 6 hours
Post operative pain assesment
The postoperative pain assessment was done after obturation, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
Measured: 24 hours
Post operative pain assesment
The postoperative pain assessment was done after obturation, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
Measured: 48 hours
Post operative pain assesment
The postoperative pain assessment was done after obturation, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
Measured: 72 hours
Post operative pain assesment
The postoperative pain assessment was done after obturation, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Apr 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth HormoneStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zakaria Abd El Aziz, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433375
- Sponsor's protocol ID
- 27/4/2023
- Status last verified
- Jul 2025
- First submitted
- 23 May 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Growth Hormone, EndoSeal MTA Sealer, and Their Combination on Healing of Periapical Pathosis(Non-Surgical Approach)
- ClinicalTrials.gov ID
- NCT06433375
- Acronym / sponsor ID
- 27/4/2023
- Conditions
- Growth Hormone, EndoSeal MTA, Periapical Pathosis
- Keywords
- Periapical Pathosis, Growth Hormone, EndoSeal MTA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 29 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.
This study aimed to evaluate the effect of growth hormone, EndoSeal MTA sealer, and their combination on Healing of Periapical Pathosis.
Detailed description
Out of 100 healthy male patients aged 18 to 40 years, 32 were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores 1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Single-rooted permanent teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth hormone group | Experimental | Procedure: Growth hormone applicationTeeth undergo Growth Hormone application before obturation using EndoSeal MTA sealer |
| Control group | Experimental | Procedure: Root canal treatmentTeeth undergo conventional root canal obturation using EndoSeal MTA sealer without any additional intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Necrotic teeth with related periapical swelling or sinus tract.
- Teeth with previous root canal fillings and /or indirect coronal restoration.
- Teeth with abnormal root canal anatomy.
- Non-restorable teeth due to insufficient coronal tooth structure.
- Teeth with periodontal disease.
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 |
|---|---|---|
| Growth hormone applicationGrowth hormone application during non-surgical root canal treatment | Procedure or surgery | Growth hormone group |
| Root canal treatmentTeeth undergo conventional root canal treatment without any additional intervention | Procedure or surgery | Control group |
Primary outcome
Post operative CBCT scan
Time frame: 6 months
Evaluation of non surgical root canal tratment healing according to CBCTPAI
Post operative CBCT scan
Time frame: 12 months
Evaluation of non surgical root canal tratment healing according to CBCTPAI
5 secondary outcomes
Post operative pain assesment
Time frame: 6 hours
Post operative pain assesment
Time frame: 24 hours
Post operative pain assesment
Time frame: 48 hours
Post operative pain assesment
Time frame: 72 hours
Post operative pain assesment
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth hormone application and Root canal treatment in people with Growth Hormone and EndoSeal MTA, run by Al-Azhar 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 0 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative CBCT scan (time frame: 6 months). 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?
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 29 Jul 2025.