NCT03435757

Brief Summary

To overcome the disadvantage of complex morphology and availability of less favorable support to retention of graft and clot stabilization in 1-, 1-2-wall periodontal defects, it was hypothesized that placement of CPS putty having the property of being easily moldable and shaped along with decortication would provide better healing outcome as compared to decortication alone in 1-, 1-2-wall periodontal defects. Therefore with this rationale, the present study is carried out to evaluate the treatment outcomes of decortication with and without use of CPS putty in 1- wall, 1-2-wall periodontal 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

January 30, 2018

Completed
20 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

February 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

January 30, 2018

Last Update Submit

February 9, 2018

Conditions

Periodontal Bone Loss

Outcome Measures

Primary Outcomes (2)

  • Bone fill,

    bone growth fill in mm

    12 months

  • CAL

    clinical attachment level gain in mm

    12 months

Study Arms (2)

Test Group OFD+IMP+CPS

EXPERIMENTAL

OFD+IMP+CPS; open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty (CPS)

Procedure: OFD+IMP+CPS

Control group (OFD+IMP)

ACTIVE COMPARATOR

OFD+IMP;open flap debridement (OFD) and intramarrow penetration (IMP)

Procedure: OFD+IMP

Interventions

OFD+IMP+CPSPROCEDURE

open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty

Test Group OFD+IMP+CPS
OFD+IMPPROCEDURE

open flap debridement (OFD) and intramarrow penetration (IMP)

Control group (OFD+IMP)

Eligibility Criteria

Age28 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with chronic periodontitis
  • Presence of non- contained osseous defect
  • Age 28 to 60 years (both males and females)
  • Completed etiological periodontal therapy (oral hygiene instructions and scaling and root planing under local anaesthesia.
  • At re-evaluation full mouth plaque score67 \< 1, full mouth bleeding score FMBS \<20%
  • Non-smokers (Current and past smokers)
  • Presence of ≥ 2mm of keratinized tissue to allow flap management
  • Tooth defect criteria:
  • Probing pocket depth ≥ 5mm
  • Clinical attachment loss ≥ 5mm
  • Associated with a 1-wall, 2-wall or a combined 1-2 wall osseous defect ≥ 3mm deep located in the interproximal area of single- and multirooted teeth (assessed by transgingival probing and radiograph, further to be confirmed after flap elevation)
  • Tooth mobility ≤ 1
  • Concerned tooth and adjoining teeth to be vital and without symptoms or signs of endodontic involvement
  • Tooth and adjoining teeth free of caries or inadequate restorations/ unrestorable tooth.
  • Absence of non-working interferences.
  • +1 more criteria

You may not qualify if:

  • Medical conditions interfering with periodontal health or wound healing
  • 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.
  • Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • Pregnant or lactating women.
  • Fractured/perforated roots.
  • Developing permanent tooth.
  • History of recent periodontal treatment within 6 months prior to study.
  • wall intrabony defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shikha Tewari

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • SHIVALI SAHARAN

    Post Graduate Institute of Dental ISciences, rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SHIKHA TEWARI, MDS

CONTACT

9416514600drshikhatewari@yahoo.com

Study Design

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

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 19, 2018

Study Start

December 1, 2017

Primary Completion

January 1, 2019

Study Completion

April 1, 2019

Last Updated

February 19, 2018

Record last verified: 2018-01

Locations

IN(1)