Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT07790796

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.

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

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

-

Treatment and study plan

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 week

Drug

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.

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 (%)

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.