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Completed

NCT Number: NCT03227367

Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

The present study is an effort to investigate the hypothesis that Platelet Rich Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation and in bone loss.

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Key information

Conditions

Periodontal Disease Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Osteoclastic Bone Loss Periodontal Atrophy Periodontal Bone Loss Periodontal Diseases Stomatognathic Diseases

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Study design

Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals refused to participate in the study. Finally, 50 participants were selected and divided into two groups, control group [Healthy individuals]: 25 Males/Females, aged 25 to 35 years and test group [Chronic periodontitis patients]: 25 Males/Females aged 30 to 45 years.

Demographic variables and periodontal parameters were measured in both the groups.The investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of Chronic Periodontitis patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Control group)

  • Subjects with age group between 30 to 45 years.
  • Non-smokers.
  • No previous history of periodontal treatment.

Inclusion criteria

(Test group)

  • Subjects with age group between 30 to 45 years.
  • Presence of atleast 20 teeth
  • More than 30% of the sites with clinical attachment loss.
  • Non-smokers.
  • No previous history of periodontal treatment.

Exclusion criteria

( both the groups)

  • Individuals with systemic disease
  • Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months.
  • Pregnant and lactating women.
  • Allergic to antibiotics.

Treatment and study plan

other : PRF

Other

mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination

Other names: others : BCP, others : PRF/BCP combination

Primary outcomes

  1. probing pocket depth

    Time frame: base line

    probing pocket dept was measured using Williams periodontal probe at base line

Secondary outcomes

  1. Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.

    Time frame: 24 hours from baseline

    Protein expression on cells was analyzed using Western blot in all the groups

  2. The activity of caspase-3 in OCs.

    Time frame: 24 hours from base line

    The activity of caspase-3 was seen in OCs in all the groups

Sponsors and collaborators

Lead sponsor

Meenakshi Ammal Dental College and Hospital

Other

Registry information

Official study title

Platelet Rich Fibrin/Biphasic Calcium Phosphate Impairs Osteoclasts Differentiation and Promotes Apoptosis by the Intrinsic Mitochondrial Pathway in Chronic Periodontitis

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 24, 2017
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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