Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth

NCT06506526 | Completed

• 1 other identifier: # 33/2017
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group): Group1(control group): The teeth will be irrigated by 2 ml 1% NaOCl after each file. Group2: The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute. Group 3: The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes. Evaluation Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold. Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively. The decrease of radiolucency and the presence of internal or external root resorption will be evaluated. Bacteriology : The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University. PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.

Conditions

Pulpal Necrosis

Outcome Measures

Primary Outcomes (4)

• Spontanous Pain

  Visual analog scale "A scale from 1 to 10 where 1 is mild pain and 10 Worst pain"

  after one month, 3 months, six months and 12 months

• Radiographical evaluation

  The change of radiolucency

  immediately after restoration, 3 months, six months and 12 months

• Radiographic examination " internal or external root resorption"

  Presence (1) or absence (0)

  immediately after restoration, 3 months, six months and 12 months

• Bacteriology

  PCR will be used for detection of Enterococcus faecalis. \- Microbiological investigation will be used for counting the number of Enterococcus faecalis

  During procedure

Study Arms (3)

Control group

ACTIVE COMPARATOR

The teeth will be irrigated by 2 ml 1% NaOCl after each file.

Procedure: Sodium hypochlorite irrigating solution

One-minute NaOCL+Chitosan

EXPERIMENTAL

The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.

Procedure: one minute NaOCL+Chitosan

Three-minute NaOCL+Chisosan

EXPERIMENTAL

The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute.

Procedure: Three minute NaOCL+Chitosan

Interventions

Sodium hypochlorite irrigating solution PROCEDURE

2 ml 1% NaOCl after each file

Control group

one minute NaOCL+Chitosan PROCEDURE

2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.

One-minute NaOCL+Chitosan

Three minute NaOCL+Chitosan PROCEDURE

2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute.

Three-minute NaOCL+Chisosan

Eligibility Criteria

• Age: 3 Months - 7 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Apparently healthy Children aged from three to seven years.
• No previous history of antibiotics for at least two weeks.
• Non- Vital primary teeth that can be fully isolated.
• Presence of clinical signs or symptoms suggesting a non-vital tooth, such as intra-oral fistula.
• Infection diagnosed by presence of periapical radiolucency in a periapical radiograph.
• Root resorption not more than one third of the root.
• Patient and parent cooperation.

You may not qualify if:

• Non-restorable tooth
• Serious reduction in bone support and/or extreme tooth mobility.
• Radiographic indication of extensive internal or external root resorption.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Mostafa youssef

Ismailia, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: July 17, 2024
• Study Start: November 14, 2022
• Primary Completion: November 14, 2023
• Study Completion: December 20, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)