NCT03836781

Brief Summary

In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling \& Root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (Balanced Block Randomization) with four blocks according to the visit time. To group A, oral chlorohexidine and to B group, the drug Ketorolac was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

February 8, 2019

Last Update Submit

July 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pocket depth

    Clinical periodontal measurements to Williams periodontal probe

    3 month

Study Arms (2)

ketorolac 3%

ACTIVE COMPARATOR

ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe

Drug: Ketorolac

chlorhexidine 2%

OTHER

chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe

Drug: Chlorhexidine 2%

Interventions

Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe

Also known as: Group A
ketorolac 3%

Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe

Also known as: Group B
chlorhexidine 2%

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with periodontitis chronic and has a 2 molar symmetrically in the lower jaw pockets of the periodontal depth of at least 5 mm and CAL 1-2 mm in at least one of the surfaces of the teeth, were selected

You may not qualify if:

  • systemic disease
  • pregnancy or breastfeeding
  • allergy drug used
  • smoking
  • medication 6. not willing to consent to participate in the study
  • Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amirhossein Farahmand

Tehran, 19, Iran

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split mouth
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant prof

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 11, 2019

Study Start

April 10, 2018

Primary Completion

June 8, 2019

Study Completion

June 15, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations