NCT02516111

Brief Summary

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

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

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

August 3, 2015

Last Update Submit

August 4, 2015

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • defect depth reduction (DDR)

    Change from baseline to 9 months

Secondary Outcomes (3)

  • change in clinical attachment level (CAL)

    Change from baseline to 9 months

  • change in probing pocket depths (PPD)

    Change from baseline to 9 months

  • change in plaque index (PI)

    Change from baseline to 9 months

Study Arms (4)

Open flap debridement group

ACTIVE COMPARATOR

SRP with Open flap debridement (OFD) alone for treating intrabony defect

Procedure: Open flap debridement (OFD)

PRF group

ACTIVE COMPARATOR

SRP with Open flap debridement (OFD) with autologous Platelet rich fibrin (PRF) placement into intrabony defect

Biological: OFD with PRF

Alendronate group

ACTIVE COMPARATOR

SRP with Open flap debridement (OFD) with 1% Alendronate (ALN) placement into intrabony defect

Drug: OFD with ALN

Atorvastatin group

ACTIVE COMPARATOR

SRP with Open flap debridement (OFD) with 1.2% Atorvastatin (ATV) placement into intrabony defect

Drug: OFD with ATV

Interventions

Open flap debridement (OFD)PROCEDURE

Oral prophylaxis followed by Open flap debridement (OFD)

Open flap debridement group
OFD with PRFBIOLOGICAL

Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect

PRF group
OFD with ALNDRUG

Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect

Alendronate group
OFD with ATVDRUG

Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect

Atorvastatin group

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

You may not qualify if:

  • Patients with a known systemic disease
  • Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group
  • On systemic ALN/ bisphosphonates or ATV/statin group
  • With aggressive periodontitis
  • Who used tobacco in any form
  • Alcoholics
  • Immunocompromised patients
  • And pregnant or lactating females were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 5, 2015

Record last verified: 2015-08