Evaluation of clinical efficacy of scaling and root planing with copper nanoparticles gel and/or chlorhexidine gel in patients with periodontitis: A randomized control trial

Material

Copper nanoparticles (particle size 30-50nm) were procured from the Nano Research Laboratory, Jharkhand, India, provided with the safety data sheet and analysis.

Preparation of CU-NP gels

Copper nanoparticles (0.005% w/v) were added to (1% w/v) weighed Carbopol 934 (soaked overnight in distilled water at 4°C) and mixed thoroughly. Methyl paraben (0.18% w/v) and propyl paraben (0.02% w/v) were added as preservatives and 1N NaOH solution was added drop wise to the above dispersion until it formed gel. The gel was refrigerated in airtight containers for further studies. The gel possessed a smooth, homogeneous texture and was free of gritty particle with transparent colour.¹³

Study setting

Inclusion criteria: The study will involve participants who have been diagnosed with generalized periodontitis stage 2 grade B and who do not have any risk factors (2017, World Workshop, classification of periodontal and peri-implant diseases and disorders).

The patients were willing to provide written informed consent and cooperate with the protocol. The primary investigator will obtain informed consent for this prospective study.

Exclusion criteria: Participants will not be allowed to participate if they have undergone periodontal therapy, antibiotic or antiseptic therapy, bleeding disorders, immunosuppressive medication therapy, or any other systemic diseases that may influence the development of periodontal disease within six months of the start of the study.

Recruitment of patients

Power analysis was performed using G*Power, version 3.0.1 (Franz Faul University, Kiel, Germany). The total determined minimum sample size was 38 rounded to 40 individuals (i.e., 20 individuals in each research subgroup) with an effect size of 0.95 and a level of significance of 0.5. See Table 1 for a schedule of events.

Allocation

The auxiliary staff will hand over the patient’s material after reading the randomization sheet. The study’s details, randomization code, and information regarding the allocation of treatments, such as tests or products, will be provided to the auxiliary staff, the randomization sheet. After reviewing the randomization sheet, the auxiliary staff dispensed the material to the patient.

Concealment mechanism: Envelopes will be prepared with an explicitly specified randomized treatment that complies with the participant’s randomization schedule. The only person with access to any of the envelopes at the location is the PI of the subject(s).

Participants: Potential subjects will be made aware of the fact that those who agree to participate in the study will do so voluntarily. Written informed consent will be obtained before beginning any investigation. Participants presenting with any other emergency dental needs will be attended before the commencement of the study. Their periodontal and gingival conditions, dental hygiene habits, and other standard clinical data will be documented on meticulously created proforma. Subjects will be evaluated in natural light using a mouth mirror, tweezers, cotton balls, and UNC -15 periodontal probe.

At the screening visit, periodontal examination of all the eligible patients were carried out and impressions were made for fabrication of stent to ensure the reproducibility of measurements during the subsequent examinations. Occlusal stents for the repositioning of probe will be fabricated with self-cured acrylic resin on the study model of the patient to cover the occlusal as well as coronal one third of the buccal and lingual surfaces of the teeth involved. Vertical grooves were made to guide the probe penetration vertically in the same plane everytime it was inserted for recording the measurements. All the clinical parameters were recorded by a single examiner.

The 40 subjects were divided into two groups. Group A - scaling and root planing followed by copper nanoparticles gel application in residual pockets, Group B - Scaling and root planing followed by chlorhexidine gel application in residual pockets using a blunt canula till the pocket is overfilled with the gel. The sites were covered with coe-pack to retain the material in the pocket as well as to prevent the ingress of oral fluids. The pack was removed after 7 days.¹⁵

The clinical outcomes will be measured in terms of Papillary Bleeding Index (PBI) (by Saxer and Muhlemann 1975), Modified Plaque Index (MPI) (by Turesky et al modification of the Quigley-Hein Index1970), Probing Pocket Depth (PPD), Relative Attachment Level (RAL) at baseline, 1 month and 3 month. Patients were asked to maintain oral hygiene and no other chemical plaque control measures to use during the study period. Patients were asked to report immediately on developing any untoward reactions. Expected adverse effects were hypersensitivity and local reaction.

At multiple points around the entire circumference of the tooth, probing pocket depth was measured in millimeters from the free gingival margin to the base of the sulcus. The floor of the sulcus was gently inspected horizontally using a periodontal probe. The UNC-15 probe was used to carefully measure the relative attachment level parallel to the long axis of the tooth until resistance was detected. The nearest millimeter was recorded from the bottom end of the occlusal stent as a reference point to the base of the pocket.

Outcome: An examiner who has been calibrated will perform all the tests. In patients with periodontitis, the Papillary Bleeding Index (PBI), Modified Plaque Index (PI), Probing Pocket Depth (PPD), and Relative Attachment Level (RAL) were used to gauge both the primary and secondary results at baseline, one month, and three months.

Statistical analysis

The statistical computation and collation of all findings will be accomplished using SPSS software (version 26© SPSS, Chicago, IL). The means and standard deviations of the data will be calculated. When P<0.05, all clinical parameters (PBI, MPI, PPD, and CAL) will be considered statistically significant.

Study status

Ongoing.

Ethics and consent

The Subjects will come from the Department of Periodontology and Implantology at Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Sawangi, Wardha. The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Ethics Committee (IEC) (DMMIMS (DU)/IEC/2021/581) on 1/10/2021. The Central Ethics Committee on Human Research (C.E.C.H.R) ethical standards were followed for medical research involving human subjects. This Randomized Control Clinical Trial is registered under Clinical Trial Registry of India (www.ctri.nic.in) (CTRI/2022/07/044047).

The patients were willing to provide written informed consent and cooperate with the protocol.¹⁹ The primary investigator will obtain informed consent for this prospective study.