Pulp NecrosisNCT07790796
Evaluation of Post-operative Pain and Bacterial Load Reduction After Application of Three Intra-canal Medications (Cocoa Husk Versus Calcium Hydroxide With and Without Cocoa) in Necrotic Mandibular First Molar.
A study testing Root canal treatment with intracanal medication by calcium hydroxide for one week., Root canal treatment with intracanal medication by cocoa husk for one week and Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week. in people with Pulp Necrosis and Postoperative Pain, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The study will aim to evaluate the postoperative pain and bacterial load after application of two intracanal medications in mandibular first molar teeth with necrotic pulp. Methods (Participants, Interventions, and Outcomes) Study Setting: This randomized clinical trial will include 36 patients, equally allocated into… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis, Postoperative Pain
- What is being tested?
- Root canal treatment with intracanal medication by calcium hydroxide for one week., Root canal treatment with intracanal medication by cocoa husk for one week and Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2026to 6 Jan 2027
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:1. Patients with an age range between 18 to 40. 2. Patients with necrotic pulp. 3. Restorable teeth. 4. Positive patient acceptance for participating in the study. 5. Type III distal and mesial canal of the first mandibular molar. 6. Patients have necrotic pulp with symptomatic apical periodontitis in mandibular first molars.
-
Exclusion Criteria:1. Pregnant females 2. Medically compromised patients. 3. Patients having analgesics before the treatment 4. If antibiotics have been administered during the past two weeks pre-operatively.
- Patients having bruxism or clenching 6. Patients have severe malocclusion associated with traumatic occlusion. 7. Teeth that have:
- Peri-apical radiolucency b. Root resorption. c. Pulp stones or calcifications. d. Previous endodontic treatment
-
Trial locations and contacts
1 site in 1 country.
About this study
The study will aim to evaluate the postoperative pain and bacterial load after application of two intracanal medications in mandibular first molar teeth with necrotic pulp.
Methods (Participants, Interventions, and Outcomes)
Read more
Study Setting:
This randomized clinical trial will include 36 patients, equally allocated into three groups (12 patients each). Participants will be recruited from the Outpatient Clinic of the Endodontic Department, Faculty of Oral and Dental Medicine, Future University in Egypt. All treatments will be performed by a postgraduate master's degree candidate using a Ritter dental unit (Germany) and Sirona digital intraoral radiography (Nanopix, size 2).
Eligibility Criteria:
Eligible participants will be 18-40 years old with necrotic pulp and symptomatic apical periodontitis in restorable mandibular first molars (Type III mesial and distal canals) and willing to participate. Exclusion criteria include pregnancy, systemic diseases, recent use of analgesics or antibiotics, bruxism or clenching, severe traumatic malocclusion, and teeth with periapical radiolucency, root resorption, pulp stones/calcifications, or previous endodontic treatment.
- Conditions
- Pulp Necrosis, Postoperative Pain
- Being tested
- Root canal treatment with intracanal medication by calcium hydroxide for one week., Root canal treatment with intracanal medication by cocoa husk for one week, Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week.
- Keywords
- Cocoa Husk, Calcium hydroxide, Intra-canal medication
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment with intracanal medication by calcium hydroxide for one week.Drug
Following cleaning and shaping of the root canal, calcium hydroxide paste will be used as an intracanal medicament for one week to reduce bacterial load before the final root canal
Root canal treatment with intracanal medication by cocoa husk for one weekDrug
Root canal treatment with intracanal medication by cocoa husk for one week
Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week.Drug
Following cleaning and shaping, no intracanal medicament will be used. The root canal will be obturated according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| using calcim hydroxide as intra canal medication | Active comparator | Not described Receives: Drug: Root canal treatment with intracanal medication by calcium hydroxide for one week. |
| cocoa husk as intra canal medication | Experimental | Not described Receives: Drug: Root canal treatment with intracanal medication by cocoa husk for one week |
| cocoa husk mixed with calcium hydroxide as intra canal medication | Experimental | Not described Receives: Drug: Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Measured: 6,12,24,48,and 72hours after root canal treatment by numerical rate scale (NRS)
Secondary outcomes (1)
bacterial load reduction
Measured: S1: after access cavity and before RCT. S2: after mechanical instrumentation S3: after intracanal medicament removal By Colony Forming Unit analysis18 CFU/ml (%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start6 Jan 2026
- Primary completion6 Jan 2027 (estimated)
- Study completion6 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Fatouh Mahmoud, Future University in Egypt
- Investigators
- fatouh, Principal investigator, future university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790796
- Sponsor's protocol ID
- FUE.REC(6)1-2026
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pain and Bacterial Load Reduction After Application of Three Intra-canal Medications (Cocoa Husk Versus Calcium Hydroxide With and Without Cocoa) in Necrotic Mandibular First Molar.
- ClinicalTrials.gov ID
- NCT07790796
- Acronym / sponsor ID
- FUE.REC(6)1-2026
- Conditions
- Pulp Necrosis, Postoperative Pain
- Keywords
- Cocoa Husk, Calcium hydroxide, Intra-canal medication
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 6 Jan 2027 (estimated)
- Study completion
- 6 Jan 2027 (estimated)
- First posted
- 27 Aug 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.
The study will aim to evaluate the postoperative pain and bacterial load after application of two intracanal medications in mandibular first molar teeth with necrotic pulp.
Methods (Participants, Interventions, and Outcomes)
Study Setting:
This randomized clinical trial will include 36 patients, equally allocated into three groups (12 patients each). Participants will be recruited from the Outpatient Clinic of the Endodontic Department, Faculty of Oral and Dental Medicine, Future University in Egypt. All treatments will be performed by a postgraduate master's degree candidate using a Ritter dental unit (Germany) and Sirona digital intraoral radiography (Nanopix, size 2).
Eligibility Criteria:
Eligible participants will be 18-40 years old with necrotic pulp and symptomatic apical periodontitis in restorable mandibular first molars (Type III mesial and distal canals) and willing to participate. Exclusion criteria include pregnancy, systemic diseases, recent use of analgesics or antibiotics, bruxism or clenching, severe traumatic malocclusion, and teeth with periapical radiolucency, root resorption, pulp stones/calcifications, or previous endodontic treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| using calcim hydroxide as intra canal medication | Active comparator | Drug: Root canal treatment with intracanal medication by calcium hydroxide for one week. |
| cocoa husk as intra canal medication | Experimental | Drug: Root canal treatment with intracanal medication by cocoa husk for one week |
| cocoa husk mixed with calcium hydroxide as intra canal medication | Experimental | Drug: Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Root canal treatment with intracanal medication by calcium hydroxide for one week.Following cleaning and shaping of the root canal, calcium hydroxide paste will be used as an intracanal medicament for one week to reduce bacterial load before the final root canal | Drug | using calcim hydroxide as intra canal medication |
| Root canal treatment with intracanal medication by cocoa husk for one weekRoot canal treatment with intracanal medication by cocoa husk for one week | Drug | cocoa husk as intra canal medication |
| Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week.Following cleaning and shaping, no intracanal medicament will be used. The root canal will be obturated according to the study protocol. | Drug | cocoa husk mixed with calcium hydroxide as intra canal medication |
Primary outcome
postoperative pain
Time frame: 6,12,24,48,and 72hours after root canal treatment by numerical rate scale (NRS)
1 secondary outcome
bacterial load reduction
Time frame: S1: after access cavity and before RCT. S2: after mechanical instrumentation S3: after intracanal medicament removal By Colony Forming Unit analysis18 CFU/ml (%)
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 27 Aug 2026.
- Individual participant dataSharing planned: Yes
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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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.
fatouh principal investigator
future university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal treatment with intracanal medication by calcium hydroxide for one week., Root canal treatment with intracanal medication by cocoa husk for one week and Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week. in people with Pulp Necrosis and Postoperative Pain, run by Future University in Egypt 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?
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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 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?
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?
postoperative pain (time frame: 6,12,24,48,and 72hours after root canal treatment by numerical rate scale (NRS)). 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 27 Aug 2026.