RGD With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect

NCT06936605 | Not Yet Recruiting

• 2 other identifiers: MINST+ RGD in Periodontitiscommittee 1051
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intrabony Defect; Periodontal Diseases; Alveolar Bone Loss

Keywords

MINST; RGD; intrabony defect

Outcome Measures

Primary Outcomes (1)

• CAL by millimeters

  Measure clinical attachment loss pre and after-intervention

  baseline, 3months and 6 months

Study Arms (3)

negative control group

PLACEBO COMPARATOR

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique

Drug: RGD Peptide

control group

PLACEBO COMPARATOR

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with placebo hydrogel

Drug: RGD Peptide

study group

ACTIVE COMPARATOR

Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with RGD hydrogel

Drug: RGD Peptide

Interventions

RGD Peptide DRUG

RGD peptide is an integrin binding site

control group; negative control group; study group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with systemic diseases, smokers, pregnant (female).
• Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.

Sponsors & Collaborators

• Minia University: lead

Related Links

• RGD in treatment of intrabony defect

MeSH Terms

Conditions

Periodontal Diseases; Alveolar Bone Loss

Interventions

arginyl-glycyl-aspartic acid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Central Study Contacts

shaimaa Hamdy, lecturer of Periodontology

CONTACT

+201030576405; shimaa.3m.sh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients do not know the type of treatment and outcomes assessor does not know type of group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in periodontology

Model Details: Groups and intervention: Patients selected in this study will be classified into three groups: * Group 1: Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with modified minimally invasive surgical technique (MINST) and RGD hydrogel injection. * Group 2: Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (MINST) and hydrogel injection. * Group : Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with (MINST) alone. Postoperative phase: 1. Routine verbal and written postoperative instructions will be given to all patients. 2. Patients will be advised to refrain from retracting the cheeks, to accomplish food mastication in areas away from surgical site, and to avoid brushing the area in the first week.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: April 15, 2025
• Primary Completion: September 20, 2025
• Study Completion: October 20, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share