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Clinical Trials/NCT06759766
NCT06759766Not yet recruitingNot Applicable

Evaluation of Antimicrobial Potency of Garlic Lemon Extract Irrigant Versus Physiological Saline Irrigant Following Partial Pulpectomy in Primary Molars: A Randomized Clinical Trial

Cairo University0 sites38 target enrollmentStarted: January 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
38
Primary Endpoint
bacterial count

Study Overview

Brief Summary

To evaluate the antimicrobial potency of Garlic Lemon extract irrigant versus physiological saline irrigant following partial pulpectomy in primary molars.

Detailed Description

Pulpectomy is a suitable treatment of primary teeth with irreversible pulpitis, necrosis, or periodontitis due to caries or trauma. Due to the complex nature of the deciduous root canal system makes total removal of necrotic tissue by instrumentation alone impossible. Therefore, irrigation is a replenishing step to create a disinfectant atmosphere inside the root canal.

A variety of antiseptic and antibacterial irrigating solutions have been used such as (NaOCl), (CHX), and (EDTA). Due to their adverse effects, safety issues and cytotoxic reactions, Herbal products can be an alternative to these irrigants based on their previous history in medical field.

Herbal extracts such as garlic (Allium sativum) Shows a wide range of therapeutic effects due to the presence of allicin, ajoene & other thiosulfinates. It has antibacterial effect against wide range of gram-positive and gram-negative bacteria, anti-inflammatory, antioxidant, antiviral, antifungal, antitumor, immunomodulatory effects and tissue-dissolving capacity (Siddique, et al., 2020). According to (Elheeny., 2019) Allium sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.

Lemon (Citrus Limon) as well has curative properties such as, antibacterial, antiviral, antifungal, anti-inflammatory, anti-cancerous activities and removal of the smear layer as well. Due to presence of ascorbic acid, phenolic acids, polyphenols, and dietary fibers.

the combination of Garlic-Lemon has been tested in adult teeth as an irrigant and showed an effective result equal to NaOCl (Siddique, et al., 2020).However, there is no studies have been performed to assess the combination of Garlic-lemon extract as an irrigant in deciduous molars.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

The blinding of operator is not possible due to the nature of the material used. The clinical outcome assessor and statistician will be blinded in this study.

Eligibility Criteria

Ages
4 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •The children's age range from four to seven years from both sexes.
  • •Presence of localized swelling, sinus and pain on percussion which indicate non vital pulp.
  • •Presence of periapical and furcation radiolucency in periapical radiograph.
  • •Absence of history of systemic disease which would contraindicate pulp therapy e.g. infective endocarditis.
  • •No previous history of antibiotics administration or last dose was taken from at least two weeks.

Exclusion Criteria

  • •Presence of advanced physiologic or pathologic root resorption in X-ray.
  • •Uncooperative children.
  • •Teeth with unrestorable crowns.
  • •Teeth with abnormal anatomy and calcified canals.

Arms & Interventions

Garlic-Lemon Extract irrigant

Active Comparator

garlic (Allium sativum) Shows a wide range of therapeutic effects due to the presence of allicin, ajoene & other thiosulfinates. It has antibacterial effect against wide range of gram-positive and gram-negative bacteria, anti-inflammatory, antioxidant, antiviral, antifungal, antitumor, immunomodulatory effects and tissue-dissolving capacity (Siddique, et al., 2020). According to (Elheeny., 2019) Allium sativum extract can be used efficiently as an irrigant for pulpectomy of primary molar root canals.

Lemon (Citrus Limon) as well has curative properties such as, antibacterial, antiviral, antifungal, anti-inflammatory, anti-cancerous activities and removal of the smear layer as well. Due to presence of ascorbic acid, phenolic acids, polyphenols, and dietary fibers.

the combination of Garlic-Lemon has been tested in adult teeth as an irrigant and showed an effective result equal to NaOCl (Siddique, et al., 2020).

Intervention: Garlic-Lemon Extract irrigant (Combination Product)

physiological saline irrigant

Active Comparator

Normal saline solution exhibits no adverse effects on the developing successors; Serves primarily to facilitate root canal cleaning during the irrigation process, in comparison to other commercial synthetic irrigants such as Sodium hypochlorite (NaOCl), Chlorhexidine (CHX), Ethylenediamine tetra acetic acid (EDTA) which exhibit potential side effects and cytotoxic reactions (Sayadizadeh et al., 2019).

Intervention: physiological saline (Other)

Outcomes

Primary Outcomes

bacterial count

Time Frame: pre and after irrigation within the same visit

colony forming unit (CFU) quantitative measure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nourhan Yasser Yousef Mohamed

principle investigator

Cairo University

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