Silver Nanoparticle-Reinforced Double Antibiotic Paste in Symptomatic Apical Periodontitis: A Randomized Controlled Trial

NCT07762599 | Not Yet Recruiting DMC

• 1 other identifier: IEC/Pharmac/2026/313
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background Apical periodontitis (AP) is an inflammatory condition of the periapical tissues. The Symptomatic Apical periodontitis (SAP) represents the active phase of the disease, presenting with pain and tenderness. In SAP, levels of inflammatory mediators such as Interleukin-1β (IL-1β) and Matrix Metalloproteinase-9 (MMP-9) are elevated in gingival crevicular fluid (GCF). Assessing these biomarkers in GCF provides a novel, non-invasive method to evaluate periapical inflammation and healing. Due to the polymicrobial nature of root canal infections, the use of Intracanal medicaments (ICM) has been recommended to achieve effective disinfection. Traditionally used ICMs have their own inherent limitations. Hence, ICMs such as Triple antibiotic paste (TAP), double antibiotic paste (DAP), Silver nanoparticles (AgNPs) and their various combinations are gaining popularity. Currently, various combinations of AgNPs with other agents such as chitosan, calcium hydroxide, antibiotics and various herbal products are being tried to improve its effectiveness when used as an ICM. However, to the best of investigators knowledge, no study reinforced the DAP with AgNPs. Hence, the current double-blind, randomized, parallel clinical trial is planned to compare the effects of DAP with and without reinforcement of AgNPs on inflammatory biomarkers (IL-1β and MMP-9), postendodontic pain, and periapical healing in SAP. Moreover, this DAP+AgNPs formulation will undergo characterization such as FTIR, TEM/SEM, Zeta potential to assess its properties. Methods A total of 50 adult participants with SAP in single-rooted teeth were randomly divided into two groups based on the type of ICM used: Group I received DAP, while Group II received DAP reinforced with AgNPs. Before starting the root canal treatment, GCF will be collected and marked as baseline. Then under rubber dam isolation all teeth underwent root canal treatment and ICM will be placed according to the specific group. Patient will be recalled after 14 days and again GCF sample will be collected after removal of the ICM. The samples will be stored at -800C for analysis. All samples will undergo enzyme-linked immunosorbent assay (ELISA) to estimate IL1β and MMP-9 levels. Pain levels will be recorded using the Numerical Rating scale (NRS) at various intervals. Data will be analyzed using STATA, SPSS or R. P value \< 0.05 will be considered statistically significant. Discussion Most conventional ICM have limited ability to penetrate where residual microorganisms often persist. Nanoparticle-based formulations such as AgNPs have gained attention because of their extremely small size, surface charge, and potent antimicrobial activity, which enable them to penetrate dentinal tubules and disrupt bacterial biofilms that are resistant to conventional antibiotics. Incorporating AgNPs into DAP could therefore enhance their antibacterial efficacy. Furthermore, since most endodontic pathogens cannot be routinely cultivated, monitoring the changes in inflammatory biomarkers in GCF provides a reliable and non-invasive method to assess the biological response and healing. Hence, the current double-blind, randomized, parallel clinical trial is planned to compare the effects of DAP with and without reinforcement of AgNPs on inflammatory biomarkers (IL-1β and MMP-9), postendodontic pain, and periapical healing in SAP. The findings may support the use of nanoparticle-assisted ICM as a safer and more effective approach for endodontic disinfection and healing

Conditions

Apical Periodontitis; Post Endodontic Pain; Periapical Healing; Inflammatory Biomarkers

Keywords

silver nanoparticles; Double antibiotic paste; Intracanal Medicament

Outcome Measures

Primary Outcomes (2)

• Change in gingival crevicular fluid IL-1 beta and MMP-9 levels

  IL-1 beta and MMP-9 levels will be measured in gingival crevicular fluid at baseline and after 14 days of intracanal medicament placement ,comparing DAP and DAP+ AgNPs group

  Baseline and 14 days post-treatment

• Change in Post Endodontic Pain intensity

  Post Endodontic Pain will be assessed using Numerical Rating Scale (NRS) at 24 hr,48hr,72hr,7 days and 14 days following intracanal medicament placement comparing DAP and DAP+AgNPs group

  Baseline and after 14 days post -treatment

Secondary Outcomes (1)

• Radiographic Periapical Healing

  3 months and 6 months post treatment

Study Arms (2)

silver nanoparticles reinforced double antibiotic paste

EXPERIMENTAL

In symptomatic apical periodontitis patients silver nanoparticles reinforced double antibiotic paste will placed as an intracanal medicament

Drug: silver nanoparticles reinforced double antibiotic paste

Standard double antibiotic paste

ACTIVE COMPARATOR

In symptomatic apical periodontitis patients double antibiotic paste will placed as an intracanal medicament

Drug: Double Antibiotic Paste

Interventions

silver nanoparticles reinforced double antibiotic paste DRUG

Silver nanoparticle reinforced double antibiotic paste placed as an intracanal medicament for symptomatic apical periodontitis patients distinguished by the incorporation of silver nanoparticles for enhanced antimicrobial activity compared to conventional double antibiotic paste.

silver nanoparticles reinforced double antibiotic paste

Double Antibiotic Paste DRUG

Standard Double Antibiotic Paste consist of ciprofloxacin and metronidazole placed as an intracanal medicament for symptomatic apical periodontitis patients .

Standard double antibiotic paste

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult participants (aged 18-60 years) with SAP and Periapical Pathology in single rooted teeth.
• Preoperative pain score will be assessed and recorded using the NRS on a scale 0 to 10. Patients will be asked to mark their current pain level on the scale of 0-10. Patients with pain level ≥7 will be included in the study (NRS categorized as none (0), mild (1-3), moderate (4-6), and severe (7-10).
• Periapical pathology will be diagnosed according to PAI and patient with PAI ≥3 will be included in the study (PAI -Score 1 Normal periapical structure, Score2: Minor changes in bone structure, Score 3 Changes in bone structure with some mineral loss, Score4: A well-defined radiolucent area, Score 5 Severe periodontitis with exacerbated features)
• Systemic Health will be assessed using ASA. Patient with ASA II will be included in the study.

You may not qualify if:

• Previous endodontic treatment
• Absence of antagonist tooth
• Teeth with Immature apex
• Severe periodontal disease or root resorption
• Use of antibiotics within 1 month or analgesics within 3 days
• Pregnancy or lactation.
• Allergy to study medicaments

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

Nagpur, Maharashtra, 441108, India

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

Ganesh R Jadhav, MDS

CONTACT

+919823649979; drganesh11@aiimsnagpur.edu.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)