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

NCT05653245 | Completed Phase 1 DMC

• 1 other identifier: periodontal regeneration
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Conditions

Periodontitis

Keywords

adhesion molecule; intrabony defect; hydrogel; Minimally invasive surgical technique

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• evaluate the clinical parameters attachment gain

  6 months follow up

• evaluate the clinical parameters

  6 months follow up

• evaluate the clinical parameters

  6 months follow up

Other Outcomes (1)

• biochemical evaluation

  1, 7,14 days follow up

Study Arms (3)

Group 1

PLACEBO COMPARATOR

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

Drug: RGD Peptide

Group 2

PLACEBO COMPARATOR

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

Drug: RGD Peptide

Group 3

ACTIVE COMPARATOR

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

Drug: RGD Peptide

Interventions

RGD Peptide DRUG

adhesion molecules

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (2)

Shaimaa Hamdy

Minya, 12345, Egypt

Location

Shaimaa Hamdy

Minya, 123, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

arginyl-glycyl-aspartic acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: periodontist

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 16, 2022
• Study Start: March 15, 2021
• Primary Completion: February 5, 2022
• Study Completion: September 9, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)