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Clinical, Anti-Inflammatory And Anti-Infective Properties Of Amniotic Membranes Used For Guided Tissue Regeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033226
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Dr R Viswa Chandra, SVS Institute of Dental Sciences

Brief Summary:
The objective of this study is to evaluate the anti-inflammatory and anti-infective properties of amniotic membrane (AM) when used for guided tissue regeneration (GTR) in periodontal bone defects.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Device: Amniotic Membrane Device: Control group (Hydroxyapatite only) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of Clinical, Anti-Inflammatory and Anti-Infective Properties of Amniotic Membranes Used For Guided Tissue Regeneration in Contained Defects
Study Start Date : March 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Durapatite

Arm Intervention/treatment
Experimental: Amniotic Membrane
The test site was treated as follows; After placement and proper condensation of natural Hydroxyapatite graft in the defect, AM was cut based on defect anatomy of surgical site and then adapted over the bone graft and alveolar bone extending from base of the flap reflection to the tooth surface.
Device: Amniotic Membrane
AM strongly resembles the oral mucosal basement membrane and possesses several types of laminins, which can promote regeneration, accelerate tissue adhesion, and preserve tissues, all of which play a key role in improved healing of periodontal lesions and might result in reduction in probing pocket depth (PPD) and decrease in clinical attachment loss (CAL)
Other Name: TMH Tissue Bank, Mumbai, India

Placebo Comparator: Control group (Hydroxyapatite only)
The control site was treated by graft placement (Hydroxyapatite) only
Device: Control group (Hydroxyapatite only)
The placebo group was treated with Hydroxyapatite graft placement only.




Primary Outcome Measures :
  1. The mean difference in levels of hBD-2/IL-1β [ Time Frame: From Baseline to One month ]
    Commercially available ELISA kits were used to quantify GCF levels of hBD-2 and IL-1β. All assay procedures were conducted according to the manufacturer's instructions and in the test, 100μl of the samples or standards were added into the respective wells in duplicate. Color development was stopped using 1% H2SO4 and absorbance of the entire plate was measured within 30 minutes by an ELISA reader at 450nm. The amounts of hBD-2 and IL-1β were calculated based on the dilutions, and the results were expressed in picograms in the 30-second GCF sample.


Secondary Outcome Measures :
  1. Bone fill assessment [ Time Frame: Baseline to 6 months ]
    The evaluation of bone fill was performed by using digital subtraction technique and morphometric area analysis by using specific tools in two image processing software.


Other Outcome Measures:
  1. Measures of periodontitis and gingivitis [ Time Frame: Baseline to 6 months ]
    Non-invasive site-specific measures of the plaque index (PI) and modified gingival index (MGI) at the baseline, 1 week, 12 weeks and 24 weeks. The PPD, CAL and bone fill were recorded at the baseline (on the day of surgery) and at the end of 12 and 24 weeks. PPD and CAL were recorded at the baseline and at the end of 12 and 24 weeks using a UNC-15 color-coded periodontal probe.



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Systemically healthy chronic periodontitis patients within the age group of 30-55 years having at least 2 periodontal pockets ≥5 mm with at least 1 pocket in each quadrant showing radiographic evidence of vertical bone loss were included in the study. Assessment of suitability for GTR membrane placement was confirmed by transgingival probing to verify the presence of two well-contained interdental bone defects in as many quadrants.

Exclusion Criteria:

Smokers, medically compromised patients, pregnant women & lactating mothers and subjects receiving periodontal therapy in the 24 weeks (6-month)-period leading to the study were not included.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033226


Locations
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India
SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Andhra Pradesh, India, 509002
Sponsors and Collaborators
SVS Institute of Dental Sciences
Investigators
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Study Chair: Anumala Naveen, MDS SVS Institute of Dental Sciences

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Responsible Party: Dr R Viswa Chandra, Primary Investigator and Director of Records, SVS Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT02033226    
Other Study ID Numbers: SVS031101
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Keywords provided by Dr R Viswa Chandra, SVS Institute of Dental Sciences:
Periodontitis
Periodontal Regeneration
Amniotic membrane
Guided tissue regeneration
Anti-inflammatory
Periodontal Therapy.
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Anti-Infective Agents