RGD With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect (MINST + RGD)

The Use of Integrin Binding Domain Loaded Hydrogel (RGD) With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect (Randomized Clinical Trial Study)

Periodontal regeneration is a complex process that involves coordinated activities and interactions of many cell types, extracellular matrix, cytokines, and specific growth factors to restore tissue integrity. The most important challenge facing periodontal regeneration is cellular insufficiency. Periodontal defects usually have a limited regenerative capacity due to their bounded surface area which is supposed to provide the wound area with a limited number of viable cells and a limited amount of biologic mediators. Cell recruitment and adhesion into the defect area are essential for cells to survive and secrete collagen.

Apoptosis is initiated when failure in adhesion in many different cell types occurs. Some periodontal treatment options failed in the reconstruction of the defect due to failure in wound stabilization and subsequent cell adhesion. Many treatment options have been developed to enhance defect stability and cellular recruitment including the use of GTM and different biologics. However, the treatment outcomes vary considerably depending on the level of the defect cellularity and the degree of cell recruitment into the defect area. For maximum outcomes, enhanced stability, vascularity, and biologics-sustained delivery were suggested. The minimally invasive surgical technique (MIST) suggested by Cortellini et al. offers a suitable level of tissue preservation that could help in defect stability and cellular adhesion. It was suggested to promote flap stability, maintain space, and maintain a greater amount of blood supply at the alveolar crest and papillary levels.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Diseases; Alveolar Bone Loss; Intrabony Defect
• Intervention / Treatment: Drug: RGD Peptide

Detailed Description

Periodontitis is an inflammatory multifactorial disease initiated by pathogenic bacteria accumulated as a biofilm on the tooth surface leading to clinical attachment loss (CAL), pocket formation (PD), bleeding on probing (BOP), and bone loss which if neglected may lead to increased tooth mobility and final tooth loss. Pathological tooth mobility may arise from extensive alveolar bone loss, traumatic occlusion, acute periodontal inflammation, and apical tooth displacement. Treating tooth mobility can be a challenging process, particularly for patients with severe periodontitis, including those in stage III or IV, who often experience a range of these symptoms. ue to compromised periodontal support. Therefore, effective treatment not only relies on periodontal therapy but also on occlusal stability and tooth splinting

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shaimaa Hamdy, lecturer of Periodontology; Phone Number: +201555035523 +201030576405; Email: shimaa.3m.sh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • All patients included will have moderate to advanced periodontitis.

  • Patients included in this study will be free from any systemic diseases according to criteria of Modified Cornell Medical Index(10).
  • Patients who had not undergone any type of regenerative periodontal therapy six months prior to the initial examination.

Exclusion Criteria:

• • Patients with systemic diseases, smokers, pregnant (female).

  • Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: negative control group; Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique	Drug: RGD Peptide; RGD peptide is an integrin binding site
Placebo Comparator: control group; Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with placebo hydrogel	Drug: RGD Peptide; RGD peptide is an integrin binding site
Active Comparator: study group; Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with RGD hydrogel	Drug: RGD Peptide; RGD peptide is an integrin binding site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAL by millimeters	Measure clinical attachment loss pre and after-intervention	baseline, 3months and 6 months

Collaborators and Investigators

• Sponsor: Minia University

Publications and helpful links

Helpful Links

• RGD in treatment of intrabony defect

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): September 20, 2025
• Study Completion (Estimated): October 20, 2025

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: RGD; MINST; intrabony defect
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss; Periodontal Diseases; Antineoplastic Agents; Arginyl-glycyl-aspartic acid
• Other Study ID Numbers: MINST+ RGD in Periodontitis; committee 1051 (Other Identifier: ethical committee faculty of dentistry minia university)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: after complete study and publishing all data well be available

Drug and device information, study documents

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