comparison of two different antimicrobial gels either alone or in combination form in patients with gum disease

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012504
• Date of registration: 12-03-2018
• Prospective Registration: No
• Primary sponsor: Pujan Acharya
• Public title: comparison of two different antimicrobial gels either alone or in combination form in patients with gum disease
• Scientific title: â??Clinical evaluation of topical metronidazole and chlorhexidine gel following scaling and root planing in patients with chronic periodontitis
• Date of first enrolment: 25-02-2014
• Target sample size: 120
• Recruitment status: Not Applicable
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22736
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 4

Countries of recruitment

Nepal

Contacts

• Name: Pujan Acharya
• Affiliation: Gorakhpur University

• Name: Dr Manoj Yadav
• Affiliation: Gorakhpur University

Key inclusion & exclusion criteria

Inclusion criteria: periodontitis with minimum of 22 teeth present,Probing depth of 4-6 mm in at least 2 teeth per quadrant,Non-smoker
Exclusion criteria: Any systemic condition that could affect the progression of periodontal disease or would require prophylactic antibiotic,Known allergy to metronidazole and chlorhexidine,Pregnancy and lactating women,Grade II and III mobility,Any teeth with furcation involvement,History of periodontal therapy 6 months back,Use of systemic or topical antimicrobial within 6 months prior to the study

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Chronic generalised Periodontitis

Intervention(s)

Intervention1: Scaling and Root Planing with Chlorhexidine: Scaling done with ultrsonic curettes and Root Planing with Hufriedy gracey curettes followed by 1% Chlorhexidine gel(25.75 gm) application in the periodontal pocket only at the first visit.
Control Intervention1: Chlorhexidine,Metronidazole,Placebo: Scaling and root planing
Control Intervention2: Scaling and Root Planing with Metronidazole: Scaling done with Ultrasonic scaler and root planing with Hufriedy gracey curettes followed by 1% Metronidazole (5.15gm) gel application only during the first or baseline visit.
Control Intervention3: Scaling and Root Planing with Combination of Chlorhexidine and Metronidazole: Scaling done with Ultrasonic scaler and root planing with Hufriedy gracey curettes followed by combination(1%Chlorhexidine and1% Metronidazole) gel application only during the first visit
Control Intervention4: Scaling and Root planing with Placebo gel: Scaling done with Ultrasonic scaler and root planing with Hufriedy gracey curettes followed by placebo gel composed of 10 gm hydroxyethyl cellulose applied only during the baseline visit.

Primary Outcome(s)

Clinical Attachment LossTimepoint: Baseline One month and Three months

Secondary Outcome(s)

Probing Pocket Depth Plaque Index and Gingival IndexTimepoint: Baseline One month and Three months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Universal College of Dental Surgery Bhairahawa Nepal

Ethics review

Status: Approved
Approval date: 01/02/2014
Contact:

Ethical Research and Academic Committee UCMS under Tribhuvan University UCMS/PG/01/14