Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing

NCT03724266 | Unknown DMC

• 1 other identifier: ahmed abdelmonam
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing

Conditions

Postoperative Pain; Healing

Outcome Measures

Primary Outcomes (1)

• change in postoperative pain after intervention of chitosan: NRS

  pain assessed by numerical rating scale, pain will be assessed using a numerical rating scale (NRS) which is proven to be a simple, valid, and a reliable pain measurement tool. The NRS consists of a series of numbers from zero to 10 with the end-points representing the extremes of pain as "no pain" and "the worst possible pain". Patients will rank their pain level by making a mark on the number they thought it represented their pain. The pain intensity is assigned into four categorical scores: 1, no pain (score 0); 2, mild (scores 1-3); 3, moderate (scores 4-6); 4, severe (scores 7-10). Pain is evaluated preoperatively and postoperatively after the initial visit at 4, 12, 24, 48, 72 hours

  4,12,24,27 hours

Secondary Outcomes (1)

• change in healing of apical periodontitis

  3,6,12 months

Study Arms (2)

chitosan

EXPERIMENTAL

chitosan as intracanal medication 0.2% in form of gel

Drug: Chitosan

calcium hydroxide

ACTIVE COMPARATOR

intracanal medication

Drug: Calcium Hydroxide

Interventions

Chitosan DRUG

chitosan will be used as intracanal medication

chitosan

Calcium Hydroxide DRUG

intracanal medication

Also known as: CaOH

calcium hydroxide

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in good general health.
• Patient's age ranging between 20-40 years with no sex predilection.
• Maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis.
• Evidence of apical radiolucency (minimum size 2 mm x 2 mm).
• Patients' acceptance to participate in the study.

You may not qualify if:

• Medically compromised patients with a severe systemic condition.
• Pregnant female patients.
• Patients who had taken any antibiotic or analgesics during the past 24 hours.
• Presence of a swelling because emergency management may include incision and drainage.
• Retreatment cases.
• Generalized periodontitis (calculus, deep pockets).
• Out of normal variations (open apex- severely curved canal- obstructed canal).

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Chitosan; Calcium Hydroxide

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants should be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd student, principle investigator

Model Details: postoperative pain after intervention

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 30, 2018
• Study Start: October 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 1, 2018

Record last verified: 2018-10