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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

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

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.

02

Conditions studied

  • Pulp Necrosis
  • Postoperative Pain

Keywords

  • Cocoa Husk
  • Calcium hydroxide
  • Intra-canal medication
03

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

-

04

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.

05

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 (%)

06

Study locations

1 site
  • Future University
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07790796
Lead sponsor
Future University in Egypt
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 ↗

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