NCT03435653

Brief Summary

To compare clinically and radiographically the efficacy of demineralized freeze-dried bone allograft with and without decortication in the treatment of periodontal intrabony defects assessed by gain in clinical attachment, reduction of pocket depth and radiographic bone fill.To evaluate clinically and radiographically the regenerative potential of demineralized freeze-dried bone graft (DFDBA) material in periodontal intrabony defects.To evaluate clinically and radiographically the regenerative potential of demineralized freeze-dried bone graft (DFDBA) when used in combination with decortication in periodontal intrabony defects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 7, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

February 1, 2018

Last Update Submit

June 5, 2018

Conditions

Periodontal Bone Loss

Outcome Measures

Primary Outcomes (2)

  • Radiographic Bone fill

    gain in bone level in mm

    12 months

  • CAL

    clinical attachment level in mm

    12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Control group OFD with DFDBA

Other: OFD with DFDBA

Test group

EXPERIMENTAL

Test group OFD with decortication and DFDBA

Other: OFD with decortication and DFDBA

Interventions

OFD with DFDBAOTHER

Control Group Open flap debridement with DFDBA Periodontal surgery will be performed in the form of open flap debridement along with placement of demineralized freeze dried bone allograft at the defect site.

Also known as: regenerative material and periodontal surgery
Control group
OFD with decortication and DFDBAOTHER

Test Group Open flap debridement with decortication and demineralised freeze dried bone allograft Open flap debridement with decortication and placement of demineralized freeze dried bone allograft at the defect site.

Also known as: regenerative material ,decortication with surgery
Test group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age-28-60 years , patients with chronic periodontitis according to criteria of Armitage GC classification system for periodontal diseases and conditions32.
  • Presence of 2-, 3-, or combined 2-3-wall intrabony defect ≥ 3 mm deep assessed by transgingival probing and intraoral periapical radiograph, to be confirmed after flap elevation.
  • Test tooth and adjoining teeth testing vital, should be free of caries or inadequate restorations.
  • Non smokers
  • Completed etiological periodontal therapy (oral hygiene instructions and scaling and root-planing with Full-Mouth Bleeding Score FMBS \< 20% and plaque index score\<1 \[Silness and Loe 1964\]33).
  • TOOTH OR DEFECT ELIGIBILITY CRITERIA-
  • , 3- or combined 2,3-wall intrabony defect.
  • Pocket probing depth ≥ 5 mm
  • CAL ≥ 5 mm.
  • Tooth mobility \< grade 1

You may not qualify if:

  • Systemic illness known to affect the periodontium or outcome of periodontal therapy.
  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Patient allergic to study medications
  • Pregnant or lactating mothers.
  • Tooth with 1wall intrabony defect.
  • Grade2, grade 3 mobile teeth.
  • Defects extending to a root furcation area.
  • Unrestorable tooth.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • Endodontically treated tooth.
  • Presence of non working interferences.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Cerebral DecorticationSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures

Study Officials

  • Amanpreet Kaur

    Post Graduate Institute of Dental Sciences, Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SATISH C NARULA, MDS

CONTACT

01262283876scnarula@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 19, 2018

Study Start

December 1, 2017

Primary Completion

January 1, 2019

Study Completion

April 1, 2019

Last Updated

June 7, 2018

Record last verified: 2018-01

Locations

IN(1)