NCT04044417

Brief Summary

Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Curcumin is effective in preventing periodontal disease destruction by targeting both bacteria and host inflammatory cells. Curcumin has anti- inflammatory, antioxidant, anticarcinogenic, antiviral, and antimicrobial functions. This study will be carried out to examine the effect of simvastatin-curcumin paste following EDTA root surface etching when used in conjunction with open flap debridement treating deep periodontal pockets (suggesting that it may have positive effect)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration for phase_4

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

August 1, 2019

Last Update Submit

August 4, 2019

Conditions

Periodontitis

Keywords

periodontitiscurcuminsimvastatinEDTA

Outcome Measures

Primary Outcomes (1)

  • clinical score

    Probing depth (PD): evaluate the average reduction in probing depth measured in millimeters. Reduction in probing depth indicates that EDTA, simvastatin, and curcumin have positive effects in treatment.

    change from base line to 6 months

Study Arms (3)

open flap debridement only

PLACEBO COMPARATOR

surgical treatment of periodontal defects

Procedure: currettage

curcumin and simvastatin

ACTIVE COMPARATOR

open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

Procedure: currettageDrug: curcumin simvastatin paste

EDTA, curcumin and simvastatin

ACTIVE COMPARATOR

open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).

Procedure: currettageDrug: curcumin simvastatin pasteDrug: EDTA root conditioning

Interventions

currettagePROCEDURE

open flap debridement

Also known as: surgical treatment of periodontal defects
EDTA, curcumin and simvastatincurcumin and simvastatinopen flap debridement only
curcumin simvastatin pasteDRUG

Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.

Also known as: open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
EDTA, curcumin and simvastatincurcumin and simvastatin
EDTA root conditioningDRUG

EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid

Also known as: open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).
EDTA, curcumin and simvastatin

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann \& Son, 1971). All these criteria were determined after phase I conventional periodontal therapy.
  • Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008).
  • Patients available during follow-up periods

You may not qualify if:

  • Smoking
  • Patient unwilling to comply with periodontal hygienic instructions
  • Patients under any long-term chronic medication
  • Vulnerable individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Interventions

CurcuminSimvastatin

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Ahmed Y Gamal, Professor

    Faculty of dentistry- Ain shams university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator of oral medicine and periodontology

Study Record Dates

First Submitted

August 1, 2019

First Posted

August 5, 2019

Study Start

August 25, 2016

Primary Completion

May 5, 2018

Study Completion

October 3, 2018

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share