Intrabony DefectMINST + RGDNCT06936605
RGD With Minimally Invasive Non-Surgical Technique in Treatment of Periodontal Intrabony Defect
A study testing RGD Peptide in people with Intrabony Defect and Periodontal Diseases, run by Minia University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Intrabony Defect, Periodontal Diseases, Alveolar Bone Loss
- What is being tested?
- RGD Peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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.
Who cannot join
- • Patients with systemic diseases, smokers, pregnant (female).
- Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
shaimaa Hamdy, lecturer of Periodontology contact
About this study
Official title: 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.
Read the 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
- Conditions
- Intrabony Defect, Periodontal Diseases, Alveolar Bone Loss
- Being tested
- RGD Peptide
- Keywords
- MINST, RGD, intrabony defect
- Medical subject headings
- Periodontal Diseases, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGD PeptideDrug
RGD peptide is an integrin binding site
| Study group | Role | What they receive |
|---|---|---|
| negative control group | Placebo comparator | Fifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique Receives: 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 Receives: 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 Receives: Drug: RGD Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAL by millimeters
Measure clinical attachment loss pre and after-intervention
Measured: baseline, 3months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony DefectStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shaimaa hamdy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936605
- Sponsor's protocol ID
- MINST+ RGD in Periodontitis
- Other IDs
- committee 1051
- Acronym
- MINST + RGD
- Status last verified
- Jan 2025
- First submitted
- 10 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after complete study and publishing all data well be available
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06936605
- Acronym / sponsor ID
- MINST + RGD / MINST+ RGD in Periodontitis
- Conditions
- Intrabony Defect, Periodontal Diseases, Alveolar Bone Loss
- Keywords
- MINST, RGD, intrabony defect
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| negative control group | Placebo comparator | Drug: RGD PeptideFifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique |
| control group | Placebo comparator | Drug: RGD PeptideFifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with placebo hydrogel |
| study group | Active comparator | Drug: RGD PeptideFifteen periodontitis patients will receive Phase I therapy, reevaluation after four weeks with minimally invasive non-surgical technique with RGD hydrogel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • All patients included will have moderate to advanced periodontitis.
Key exclusion criteria (2 listed)
- • Patients with systemic diseases, smokers, pregnant (female).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGD PeptideRGD peptide is an integrin binding site | Drug | control group, negative control group, study group |
Primary outcome
CAL by millimeters
Time frame: baseline, 3months and 6 months
Measure clinical attachment loss pre and after-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- RGD in treatment of intrabony defectLink provided by the sponsor.
- Individual participant dataSharing planned: No. after complete study and publishing all data well be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
shaimaa Hamdy, lecturer of Periodontology contact
Questions about this trial
What is this clinical trial studying?
A study testing RGD Peptide in people with Intrabony Defect and Periodontal Diseases, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa Hamdy, lecturer of Periodontology (+201030576405 ext. +201555035523, shimaa.3m.sh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAL by millimeters (time frame: baseline, 3months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.