Clinical, Anti-Inflammatory And Anti-Infective Properties Of Amniotic Membranes Used For Guided Tissue Regeneration
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|ClinicalTrials.gov Identifier: NCT02033226|
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : December 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Device: Amniotic Membrane Device: Control group (Hydroxyapatite only)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
- 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.
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033226
|SVS Institute of Dental Sciences, Mahabubnagar|
|Hyderabad, Andhra Pradesh, India, 509002|
|Study Chair:||Anumala Naveen, MDS||SVS Institute of Dental Sciences|