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Active, not recruitingNCT07790796Updated Aug 27, 2026

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.

An interventional study of Root canal treatment with intracanal medication by calcium hydroxide for one week. and Root canal treatment with intracanal medication by cocoa husk for one week in Pulp Necrosis and Postoperative Pain, sponsored by Future University in Egypt. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2026, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 43 studies in Dental Pulp Necrosis with a site in Egypt — 12 open to participants now, 16 under way, 1 of them phase 3. Dental Pulp Necrosis · Egypt.

Planned enrollment
25th of 43
36 · median 40
Started
2026
with 6 others
No phase
31 of 43
9 open now
Primary completion
2027-01
later than 8 of 15 live
Registered
41st of 43
by date
Lead sponsor
4 of 43
Future University in Egypt

Among the 43 studies in Dental Pulp Necrosis with a site in Egypt, this one is the 25th largest by planned enrollment, is one of 7 that started in 2026, is one of 31 with no phase, reaches primary completion later than 8 of the 15 other live ones, and was the 41st registered.

Dental Pulp Necrosis

157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.

Browse Dental Pulp Necrosis studies →

Open to participants now

12 of the 43 studies in Dental Pulp Necrosis with a site in Egypt are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 15 Dental Pulp Necrosis studies recruiting now, 6 (40%) set no upper age limit and 7 (47%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.

This study: 18 Years to 40 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 43 studies in Dental Pulp Necrosis with a site in Egypt, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Pulp Necrosis
  • Postoperative Pain

Keywords

  • Cocoa Husk
  • Calcium hydroxide
  • Intra-canal medication
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

5. Patients having bruxism or clenching 6. Patients have severe malocclusion associated with traumatic occlusion. 7. Teeth that have:

a. Peri-apical radiolucency b. Root resorption. c. Pulp stones or calcifications. d. Previous endodontic treatment

-

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    using calcim hydroxide as intra canal medication

    Drug: Root canal treatment with intracanal medication by calcium hydroxide for one week.

  • Experimental
    cocoa husk as intra canal medication

    Drug: Root canal treatment with intracanal medication by cocoa husk for one week

  • Experimental
    cocoa husk mixed with calcium hydroxide as intra canal medication

    Drug: Root canal treatment with intracanal medication by calcium hydroxide with cocoa husk for one week.

Interventions

  • DrugRoot 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

  • DrugRoot canal treatment with intracanal medication by cocoa husk for one week

    Root canal treatment with intracanal medication by cocoa husk for one week

  • DrugRoot 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.

06

What researchers measure

Primary outcomes

  1. postoperative pain

    Time frame: 6,12,24,48,and 72hours after root canal treatment by numerical rate scale (NRS)

Secondary outcomes

  1. 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 (%)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.

Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 12 months is below that.

Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2026
First posted
Aug 27, 2026
StartActual
Jan 6, 2026
Primary completionEst.
Jan 6, 2027
CompletionEst.
Jan 6, 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07790796
Responsible party
Amira Fatouh Mahmoud (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., Future University in Egypt) — Principal investigator
First posted
Aug 27, 2026
Start date
Jan 6, 2026
Primary completion
Jan 6, 2027 (estimated)
Completion
Jan 6, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

fatouh
principal investigator · future university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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