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.

NCT07790796 | Active Not Recruiting DMC

• 1 other identifier: FUE.REC(6)1-2026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulp Necrosis; Postoperative Pain

Keywords

Cocoa Husk; Calcium hydroxide; Intra-canal medication

Outcome Measures

Primary Outcomes (1)

• postoperative pain

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

Secondary Outcomes (1)

• bacterial load reduction

  S1: after access cavity and before RCT. S2: after mechanical instrumentation S3: after intracanal medicament removal By Colony Forming Unit analysis18 CFU/ml (%)

Study Arms (3)

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.

Interventions

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

using calcim hydroxide as intra canal medication

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

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

cocoa husk as intra canal medication

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.

cocoa husk mixed with calcium hydroxide as intra canal medication

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• fatouh

  future university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 27, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): January 6, 2027
• Study Completion (Estimated): January 6, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)