Periodontal Diseases
Conditions
Keywords
Periodontal Diseases, Bone Regeneration, Dental Pulp Stem Cell
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.
Interventions
GENETICDPSC injection
A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.
OTHERPlacebo
A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.
Sponsors
Songlin Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year | Baseline and 1 year after intervention. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactSonglin Wang, Ph.D
Outcome results
None listed