NCT02523651

Brief Summary

The purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal disease.

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2014

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

June 10, 2015

Last Update Submit

August 13, 2015

Conditions

Periodontal Diseases

Keywords

Periodontal DiseasesBone RegenerationDental Pulp Stem Cell

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year

    Baseline and 1 year after intervention.

Secondary Outcomes (4)

  • Quigley-Hein plaque index (QHI)

    Baseline

  • Change from Baseline Bleeding on probing (BoP) at 1 year

    Baseline and 1 year after intervention.

  • Change from Baseline Probing depth (PD) at 1 year

    Baseline and 1 year after intervention.

  • Change from Baseline Clinical attachment level (CAL) at 1 year

    Baseline and 1 year after intervention

Study Arms (2)

DPSC injection

EXPERIMENTAL

20 patients will receive DPSC injection（1000000 cells/ 0.5ml） at the local periodontal defects immediately after periodontal scaling and root planing.

Genetic: DPSC injection

Placebo control

PLACEBO COMPARATOR

20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing.

Other: Placebo

Interventions

DPSC injectionGENETIC

A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.

DPSC injection
PlaceboOTHER

A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.

Placebo control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of periodontal disease will be based on clinical assessment of:
  • Quigley-Hein index (QHI)
  • Bleeding on Probing (BoP)
  • Pocket Probing Depth (PD)
  • gingival recession (GR)
  • Clinical Attachment Level (CAL)
  • furcation involvement,and
  • radiographical assessment. All patients at the base line of this study should have been received the initial treatment and reached the qualified level of oral hygiene to be included in the next stage.

You may not qualify if:

  • Pregnant,
  • smokers,
  • immunosuppressed or diabetes patients,
  • patients exhibit gingival hypertrophy,
  • require premedication, and
  • who have been taking systemic anti-inflammatory medications, or
  • have taken antibiotics or
  • received periodontal instrumentation within 6 months prior to the study, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University School of Stomatology

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Songlin Wang, Ph.D

    Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology

    STUDY DIRECTOR

Central Study Contacts

Songlin Wang, Ph.D

CONTACT

+86 13601324511slwang@ccmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Vice President of Capital Medical University

Study Record Dates

First Submitted

June 10, 2015

First Posted

August 14, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

August 14, 2015

Record last verified: 2015-08

Locations

CN(1)