Periodontal Intrabony DefectsNCT05177198
Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects.
A study testing M-MIST + Clindamycin augmented PRF and M-MIST + PRF in people with Periodontal Intrabony Defects, run by Cairo University.
Trial summary
Periodontal infections in the oral cavity are strongly associated with clinical outcomes of both regenerative and conventional surgical procedures and should receive proper attention. It is evident with the available data that PRF has antimicrobial activity against microbial pathogens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Intrabony Defects
- What is being tested?
- M-MIST + Clindamycin augmented PRF and M-MIST + PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient-related criteria:
- Patient consulting in the outpatient clinic.
- Able to tolerate surgical periodontal procedures.
- Patient ready to perform oral hygiene instructions.
- Compliance with the maintenance program.
- Provide informed consent.
Show all 10Show fewer
- Accepts the 12 months follow-up period.
- Teeth related criteria:
- Mature permanent tooth.
- Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm.
Who cannot join
- Patient-related criteria:
- Medically compromised patients.
- Pregnant or nursing women.
- Uncooperative patients.
- Smokers.
- Teeth related criteria:
Show all 10Show fewer
- Teeth with one wall intra-bony defect.
- Teeth with supra-bony defects.
- Teeth with grade II or III mobility.
- Teeth with proximal carious defects or proximal faulty restorations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial
Periodontal infections in the oral cavity are strongly associated with clinical outcomes of both regenerative and conventional surgical procedures and should receive proper attention. It is evident with the available data that PRF has antimicrobial activity against microbial pathogens. Clindamycin is an effective antibiotic against anaerobic bacteria and it achieves higher levels of antimicrobial activity than other antibiotics. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects.
Read the detailed description
Many factors had to be taken into consideration while treating intrabony defects to achieve the concept of periodontal regeneration. PRF is a material that contains growth factors enmeshed in the fibrin network resulting in their sustained release over a period of time that can accelerate the wound healing process. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects. The purpose of combination between the PRF and Clindamycin is for establishing a simple and practical method that gives antimicrobial properties to PRF and to provide evidence of its effectiveness, and that this may provide additional advantage and reduces the need for systemic antibiotics in a variety of oral surgical procedures. Protection of the regenerating area should be provided through the specifically designed surgical approaches. These different surgical approaches developed over time include differences in terms of flap design and suturing technique. Therefore, successful wound healing was strongly influenced by preservation of the microvasculature of soft tissues as well as by revascularization rates. The Minimally Invasive Surgical Technique (MIST) was proposed by to draw the aspects of wound and blood clot stability and primary wound closure for blood-clot protection. These concepts were further strengthened with the Modified Minimally Invasive Surgical Technique M-MIST, that further incorporated the concept of space provision for the process of regeneration. For this, the effect of Clindamycin augmented PRF together with M-MIST on the clinical and radiographic outcomes in the treatment of periodontal intrabony defects need to be evaluated for clinical effectiveness
- Conditions
- Periodontal Intrabony Defects
- Being tested
- M-MIST + Clindamycin augmented PRF, M-MIST + PRF
- Keywords
- modified minimally invasive, Clindamycin, platelet-rich fibrin, intrabony defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-MIST + Clindamycin augmented PRFProcedure or surgery
modified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin.
M-MIST + PRFProcedure or surgery
modified minimally invasive surgical technique with platelet-rich fibrin alone.
| Study group | Role | What they receive |
|---|---|---|
| Test group (M-MIST + Clindamycin augmented PRF) | Experimental | Patients will be selected with probing pocket depth PD ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm, with vertical defects as detected in periapical radiographs will be treated with modified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin. Receives: Procedure: M-MIST + Clindamycin augmented PRF |
| Control group (M-MIST + PRF) | Experimental | Patients will be selected with probing pocket depth PD ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm, with vertical defects as detected in periapical radiographs will be treated with modified minimally invasive surgical technique with platelet-rich fibrin alone . Receives: Procedure: M-MIST + PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level ( CAL)
Measured from the CEJ to the bottom of the gingival sulcus.
Measured: 9 months
Secondary outcomes (6)
Probing Depth (PD)
Measured from the gingival margin to the bottom of the gingival sulcus.
Measured: 9 months
Radiographic linear defect depth
Measured as the depth of intra-osseous defect from the alveolar crest to the defect base
Measured: 9 months
Radiographic defect bone density
The region of interest (ROI) is outlined, through drawing an outline corresponding to the demarcating walls of the intra-osseous defect and mean grey values are calculated
Measured: 9 months
Gingival recession
Measured from the CEJ to the most apical extension of the gingival margin.
Measured: 9 months
Plaque index
Scores 0,1,2,3
Measured: 9 months
Gingival index
Scores 0,1,2,3
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study startMar 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Intrabony DefectsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Yusri El-Sayed El-Ashry, Cairo University
- Investigators
- Sarah Yusri, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177198
- Sponsor's protocol ID
- PER332
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Effects of Modified Minimally Invasive Surgical Technique With Clindamycin Augmented Platelet-rich Fibrin Versus Platelet-rich Fibrin Alone for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05177198
- Acronym / sponsor ID
- PER332
- Conditions
- Periodontal Intrabony Defects
- Keywords
- modified minimally invasive, Clindamycin, platelet-rich fibrin, intrabony defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Jan 2022 (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 infections in the oral cavity are strongly associated with clinical outcomes of both regenerative and conventional surgical procedures and should receive proper attention. It is evident with the available data that PRF has antimicrobial activity against microbial pathogens. Clindamycin is an effective antibiotic against anaerobic bacteria and it achieves higher levels of antimicrobial activity than other antibiotics. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects.
Detailed description
Many factors had to be taken into consideration while treating intrabony defects to achieve the concept of periodontal regeneration. PRF is a material that contains growth factors enmeshed in the fibrin network resulting in their sustained release over a period of time that can accelerate the wound healing process. The use of PRF alone or in combination with other biomaterials (such as pharmacologic agents) provided safe and promising results in the form of improvements in clinical and radiographic parameters in the management of periodontal osseous defects. The purpose of combination between the PRF and Clindamycin is for establishing a simple and practical method that gives antimicrobial properties to PRF and to provide evidence of its effectiveness, and that this may provide additional advantage and reduces the need for systemic antibiotics in a variety of oral surgical procedures. Protection of the regenerating area should be provided through the specifically designed surgical approaches. These different surgical approaches developed over time include differences in terms of flap design and suturing technique. Therefore, successful wound healing was strongly influenced by preservation of the microvasculature of soft tissues as well as by revascularization rates. The Minimally Invasive Surgical Technique (MIST) was proposed by to draw the aspects of wound and blood clot stability and primary wound closure for blood-clot protection. These concepts were further strengthened with the Modified Minimally Invasive Surgical Technique M-MIST, that further incorporated the concept of space provision for the process of regeneration. For this, the effect of Clindamycin augmented PRF together with M-MIST on the clinical and radiographic outcomes in the treatment of periodontal intrabony defects need to be evaluated for clinical effectiveness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (M-MIST + Clindamycin augmented PRF) | Experimental | Procedure: M-MIST + Clindamycin augmented PRFPatients will be selected with probing pocket depth PD ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm, with vertical defects as detected in periapical radiographs will be treated with modified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin. |
| Control group (M-MIST + PRF) | Experimental | Procedure: M-MIST + PRFPatients will be selected with probing pocket depth PD ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm, with vertical defects as detected in periapical radiographs will be treated with modified minimally invasive surgical technique with platelet-rich fibrin alone . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient-related criteria:
- Teeth related criteria:
Key exclusion criteria (10 listed)
- Patient-related criteria:
- Teeth related criteria:
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 |
|---|---|---|
| M-MIST + Clindamycin augmented PRFmodified minimally invasive surgical technique with Clindamycin (at concentration of 150 mg/ml) augmented platelet-rich fibrin. | Procedure or surgery | Test group (M-MIST + Clindamycin augmented PRF) |
| M-MIST + PRFmodified minimally invasive surgical technique with platelet-rich fibrin alone. | Procedure or surgery | Control group (M-MIST + PRF) |
Primary outcome
Clinical attachment level ( CAL)
Time frame: 9 months
Measured from the CEJ to the bottom of the gingival sulcus.
6 secondary outcomes
Probing Depth (PD)
Time frame: 9 months
Radiographic linear defect depth
Time frame: 9 months
Radiographic defect bone density
Time frame: 9 months
Gingival recession
Time frame: 9 months
Plaque index
Time frame: 9 months
Gingival index
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontal Intrabony Defects
Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Not yet recruiting
Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects
Intrabony Periodontal Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
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. This study is not recruiting at the moment.
Sarah Yusri principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing M-MIST + Clindamycin augmented PRF and M-MIST + PRF in people with Periodontal Intrabony Defects, run by Cairo 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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Feb 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Yusri (+201221036308, sarah.elsayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level ( CAL) (time frame: 9 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 11 Feb 2022.