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The Use of Adhesion Molecule Loaded Hydrogel With Minimally Invasive Surgical Technique in Treatment of Periodontal Intrabony Defect

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
RGD Peptide
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring adhesion molecule, intrabony defect, hydrogel, Minimally invasive surgical technique

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Patients with diagnosis of periodontitis (stage III or IV and grade B or C) according to new American Academy of Periodontology classification (Tonetti et al., 2018a) (Nguyen et al., 2021). Selected patients of both sexes were 20-55 years old. All single and multiple rooted teeth in both maxilla and mandible. Presence of interdental periodontal pocket with intrabony defect. Patients were free from any systemic diseases that could alter their periodontal status, complicate the surgical treatment, or affect healing according to Modified Cornell Index (Abramson, 1966). No antibiotics or any medications that affect bone or soft tissue condition were taken during the last six months. Exclusion Criteria: Patients who received regenerative periodontal therapy last 6 months before the initial examination. Pregnant or lactating females. Smokers were not included as participants in this study. Patients not committed to oral hygiene after the re-evaluation of phase I therapy. Teeth with mobility more than Grade I. Third molars.

Sites / Locations

  • Shaimaa Hamdy
  • Shaimaa Hamdy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with modified minimally invasive surgical technique (M-MIST) alone

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and hydrogel injection

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and RGD peptide hydrogel.

Outcomes

Primary Outcome Measures

evaluation of intrabony component dimension component dimension
evaluation of intrabony component dimension (defect base fill) length measured by millimeters
evaluation of intrabony component dimension
crestal bone level length measured by millimeters
evaluation of intrabony component dimension
defect width measured by millimeters

Secondary Outcome Measures

evaluate the clinical parameters attachment gain
The secondary outcomes were to evaluate the clinical attachment gain measured by millimeters
evaluate the clinical parameters
pocket depth reduction measured by millimeters
evaluate the clinical parameters
full-mouth plaque index, full mouth sulcular bleeding index by score

Full Information

First Posted
November 29, 2022
Last Updated
December 7, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05653245
Brief Title
The Use of Adhesion Molecule Loaded Hydrogel With Minimally Invasive Surgical Technique in Treatment of Periodontal Intrabony Defect
Official Title
The Use of Adhesion Molecule Loaded Hydrogel With Minimally Invasive Surgical Technique in Treatment of Periodontal Intrabony Defect (Randomized Clinical and Biochemical Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
February 5, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary aim of the study is to evaluate efficacy of RGD adhesion molecule loaded hydrogel with minimally invasive surgical technique in treatment of periodontal intrabony defect at baseline and 6months. Secondary outcome is the biochemical evaluation to detect bone morphogenetic proteins level
Detailed Description
Periodontitis is a multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by clinical attachment loss caused by the destruction of the periodontal ligament and loss of supporting bone. One of periodontal therapy goals is regeneration of the lost periodontal attachment apparatus. . To regenerate healthy periodontal tissue, various clinical techniques were developed to prevent downward epithelial migration and promote periodontal tissue regeneration by the remaining periodontal ligament (PDL) cells or osteoblasts such as open flap debridement (OFD), natural or synthetic filling materials and guided tissue regeneration (GTR). . Tissue engineering has become one of the most commonly used approaches for bone tissue reconstruction and regeneration, injectable hydrogels have attracted the attention of biomaterials scientists for bone tissue-engineering applications, because they can replace regenerative surgery with a minimally invasive injection method and can form any desired shape, to match irregular defects. Various injectable hydrogels with good moldability and 3D structures have been widely investigated for use in bone tissue engineering. . Recently a variety of bioactive peptides have been studied and applied for the promotion of bone regeneration to repair local bone defects or treat other bone diseases including extracellular matrix (ECM)- derived peptides, bone morphogenetic proteins (BMPs)-derived peptides and others. . The arginyl-glycyl-aspartic acid (RGD) peptide is one of bioactive peptides which is the cardinal integrin-binding domain and presents in many extracellular matrix proteins, such as fibronectin and vitronectin. As a part of cell surface signalling, RGD peptide can enhance the expression of osteocalcin (OCN), osteopontin (OPN) and BMP to ensure osteoblast proliferation, differentiation and mineralization. . The induction of bone depending on the concentration of BMPs which considered important bone biological factors that play essential roles in osteogenesis. BMPs are members of secreted signaling proteins that belong to transforming growth factor beta (TGF-β) superfamily. It has been demonstrated that BMPs induce bone formation by differentiating mesenchymal stem cells to osteoblastic cells

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
adhesion molecule, intrabony defect, hydrogel, Minimally invasive surgical technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The total of 45 infra-bony defects were randomly divided into 3 equal groups (n=15 each) by simple randomization and all surgeries were done by the same periodontist (Sh.H): Group 1: Fifteen intra-bony defect sites were treated with modified minimally invasive surgical technique M-MIST alone. Group 2: Fifteen intra-bony defect sites were treated with M-MIST and placebo hydrogel injection. Group3: Fifteen intra-bony defect sites were treated with M-MIST and RGD peptide hydrogel injection.
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with modified minimally invasive surgical technique (M-MIST) alone
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and hydrogel injection
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and RGD peptide hydrogel.
Intervention Type
Drug
Intervention Name(s)
RGD Peptide
Intervention Description
adhesion molecules
Primary Outcome Measure Information:
Title
evaluation of intrabony component dimension component dimension
Description
evaluation of intrabony component dimension (defect base fill) length measured by millimeters
Time Frame
6 months follow up
Title
evaluation of intrabony component dimension
Description
crestal bone level length measured by millimeters
Time Frame
6 months follow up
Title
evaluation of intrabony component dimension
Description
defect width measured by millimeters
Time Frame
6 months follow up
Secondary Outcome Measure Information:
Title
evaluate the clinical parameters attachment gain
Description
The secondary outcomes were to evaluate the clinical attachment gain measured by millimeters
Time Frame
6 months follow up
Title
evaluate the clinical parameters
Description
pocket depth reduction measured by millimeters
Time Frame
6 months follow up
Title
evaluate the clinical parameters
Description
full-mouth plaque index, full mouth sulcular bleeding index by score
Time Frame
6 months follow up
Other Pre-specified Outcome Measures:
Title
biochemical evaluation
Description
measure bone morphogenetic protein level in gingival crevicular fluid by ELIST test
Time Frame
1, 7,14 days follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Patients with diagnosis of periodontitis (stage III or IV and grade B or C) according to new American Academy of Periodontology classification (Tonetti et al., 2018a) (Nguyen et al., 2021). Selected patients of both sexes were 20-55 years old. All single and multiple rooted teeth in both maxilla and mandible. Presence of interdental periodontal pocket with intrabony defect. Patients were free from any systemic diseases that could alter their periodontal status, complicate the surgical treatment, or affect healing according to Modified Cornell Index (Abramson, 1966). No antibiotics or any medications that affect bone or soft tissue condition were taken during the last six months. Exclusion Criteria: Patients who received regenerative periodontal therapy last 6 months before the initial examination. Pregnant or lactating females. Smokers were not included as participants in this study. Patients not committed to oral hygiene after the re-evaluation of phase I therapy. Teeth with mobility more than Grade I. Third molars.
Facility Information:
Facility Name
Shaimaa Hamdy
City
Minya
ZIP/Postal Code
12345
Country
Egypt
Facility Name
Shaimaa Hamdy
City
Minya
ZIP/Postal Code
123
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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The Use of Adhesion Molecule Loaded Hydrogel With Minimally Invasive Surgical Technique in Treatment of Periodontal Intrabony Defect

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