Clinical trial NCT02523651: Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Stem Cells Injection Therapy
Official title: Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Periodontal Diseases
Keywords: Periodontal Diseases
Bone Regeneration
Dental Pulp Stem Cell
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study will involve 40 patients who were diagnosed as chronic periodontitis will receive periodontal scaling and root planing. Patients will randomly be divided at the base line into two groups.In test group, 20 chronic periodontitis patients will be treated using local DPSC injection. Whereas, a control group will contain 20 patients who will be treated using placebo. Clinical examination including Quigley-Hein plaque index (QHI), bleeding on probing (BoP), probing depth (PD), clinical attachment level (CAL), and gingival recession (GR) will be perform in different time points during the study. Radiographic and clinical examination will be carried out during the late healing phase up to 12 months post operation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year
timeFrame: Baseline and 1 year after intervention.
Secondary outcomes:
measure: Quigley-Hein plaque index (QHI)
timeFrame: Baseline
measure: Change from Baseline Bleeding on probing (BoP) at 1 year
timeFrame: Baseline and 1 year after intervention.
measure: Change from Baseline Probing depth (PD) at 1 year
timeFrame: Baseline and 1 year after intervention.
measure: Change from Baseline Clinical attachment level (CAL) at 1 year
timeFrame: Baseline and 1 year after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University School of Stomatology
state: Beijing
Study officials:
affiliation: Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction， Capital Medical University School of Stomatology
name: Songlin Wang, Ph.D
role: STUDY_DIRECTOR
References: