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

The Use of Adhesion Molecule Loaded Hydrogel With Minimally Invasive Surgical Technique in Treatment of Periodontal Intrabony Defect (Randomized Clinical and Biochemical Study)

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

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: RGD Peptide

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 12345
    • Shaimaa Hamdy
  • Minya, Egypt, 123
    • Shaimaa Hamdy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1; Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with modified minimally invasive surgical technique (M-MIST) alone	Drug: RGD Peptide; adhesion molecules
Placebo Comparator: Group 2; Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and hydrogel injection	Drug: RGD Peptide; adhesion molecules
Active Comparator: Group 3; Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (M-MIST) and RGD peptide hydrogel.	Drug: RGD Peptide; adhesion molecules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of intrabony component dimension component dimension	evaluation of intrabony component dimension (defect base fill) length measured by millimeters	6 months follow up
evaluation of intrabony component dimension	crestal bone level length measured by millimeters	6 months follow up
evaluation of intrabony component dimension	defect width measured by millimeters	6 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the clinical parameters attachment gain	The secondary outcomes were to evaluate the clinical attachment gain measured by millimeters	6 months follow up
evaluate the clinical parameters	pocket depth reduction measured by millimeters	6 months follow up
evaluate the clinical parameters	full-mouth plaque index, full mouth sulcular bleeding index by score	6 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical evaluation	measure bone morphogenetic protein level in gingival crevicular fluid by ELIST test	1, 7,14 days follow up

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): February 5, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: hydrogel; Minimally invasive surgical technique; adhesion molecule; intrabony defect
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Fibrosis; Cicatrix; Periodontitis; Tissue Adhesions; Antineoplastic Agents; Arginyl-glycyl-aspartic acid
• Other Study ID Numbers: periodontal regeneration

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No