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

NCT02033226 | Completed Phase 3 DMC

• 1 other identifier: SVS031101
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Periodontitis; Periodontal Regeneration; Amniotic membrane; Guided tissue regeneration; Anti-inflammatory; Periodontal Therapy.

Outcome Measures

Primary Outcomes (1)

• The mean difference in levels of hBD-2/IL-1β

  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.

  From Baseline to One month

Secondary Outcomes (1)

• Bone fill assessment

  Baseline to 6 months

Other Outcomes (1)

• Measures of periodontitis and gingivitis

  Baseline to 6 months

Study Arms (2)

Amniotic Membrane

EXPERIMENTAL

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

Control group (Hydroxyapatite only)

PLACEBO COMPARATOR

The control site was treated by graft placement (Hydroxyapatite) only

Device: Control group (Hydroxyapatite only)

Interventions

Amniotic Membrane DEVICE

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)

Also known as: TMH Tissue Bank, Mumbai, India

Amniotic Membrane

Control group (Hydroxyapatite only) DEVICE

The placebo group was treated with Hydroxyapatite graft placement only.

Control group (Hydroxyapatite only)

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Biological Dressings; Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anumala Naveen, MDS

  SVS Institute of Dental Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Director of Records

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

IN (1)