Periodontal DiseasesNCT06591416
Minimally Invasive Surgical Technique in Management of Intrabony Defects
A study testing minimally invasive surgical technique and minimally invasive surgical technique with granulation tissue preservation in people with Periodontal Diseases, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
In the fast-growing era of contemporary periodontology, the understanding of biological concepts in wound healing together with the evolution of the flap design and biomaterials applied in periodontal regeneration allowed for improved minimally invasive surgical techniques. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- minimally invasive surgical technique and minimally invasive surgical technique with granulation tissue preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2023to 21 Aug 2024
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age ranged from 30 to 50 years old for both genders.
- Patients are medically free according to the American society of anesthesiologists (ASA) considered as ASA I.
- The selected participants with a diagnosis stage III grade B periodontitis.
- Defect morphology: Isolated interproximal infrabony defect of at least 5mm CAL which does not extend beyond the adjacent interproximal region.
- Optimal compliance as assessed during the case related phase I therapy and evidenced by no missed treatment appointments and positive attitude toward oral hygiene.
- Bleeding on probing <25%.
Who cannot join
- Smoker and pregnant patients.
- Multiple, interconnected vertical defects.
- Generalized horizontal bone defects.
- Teeth with incorrect endodontic treatment or restoration.
- Stage I, II or IV periodontitis.
- Patient who need complex prosthetic rehabilitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Surgical Technique with and Without Granulation Tissue Preservation Using a Combination of Β Tri-Calcium Phosphate and Hyaluronic Acid Gel
In the fast-growing era of contemporary periodontology, the understanding of biological concepts in wound healing together with the evolution of the flap design and biomaterials applied in periodontal regeneration allowed for improved minimally invasive surgical techniques. As minimally invasive approaches reduce the surgical trauma, maintain soft tissue support which allow stable primary closure of the wound. These advantages have led more researchers to apply the concept of minimally invasive surgical techniques (MISTs) in the treatment of infrabony lesions.
Granulation tissue is an immature connective tissue that appears naturally during chronic inflammation or wound healing. This tissue is not a cause of periodontitis.
Read more
So, no need to remove it during periodontal treatment. The aim of preservation of the defect-filling granulation tissue after detachment of its base is assumed to act as a soft tissue support, and to increase wound stability especially in the area of the interdental papilla and avoid post-operative marginal recession. One of the alloplastic bone grafts is βeta tri-calcium phosphate (β-TCP). β-TCP has been widely used in periodontal regeneration, where many studies used beta tri-calcium phosphate alone or in combination with other grafting materials in different surgical regenerative procedures have shown promising results for bone filling and new vital bone formation. Hyaluronic acid gel shows anti-inflammatory, antibacterial, and antioxidant properties in the treatment of periodontal diseases. In addition, due to its viscoelastic properties, it can be used as an adjunct to maintain space during periodontal tissue regeneration.
A concentration of 0.8% hyaluronic acid gel has been used effectively in the non-surgical and surgical management of periodontal diseases.
Aim of The Study The aim of the present study is to evaluate the effects of the minimally invasive surgical technique with and without granulation tissue preservation using a combination of beta tri calcium phosphate and hyaluronic acid gel.
- Conditions
- Periodontal Diseases
- Being tested
- minimally invasive surgical technique, minimally invasive surgical technique with granulation tissue preservation
- Keywords
- Minimally invasive surgical technique, Granulation tissue preservation, infrabony defect
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive surgical techniqueProcedure or surgery
minimally invasive surgical technique
minimally invasive surgical technique with granulation tissue preservationProcedure or surgery
minimally invasive surgical technique with granulation tissue preservation
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgical technique with total removal of granulation tissue | Active comparator | Minimally invasive surgical technique with total removal of granulation tissue Receives: Procedure: minimally invasive surgical technique |
| Minimally invasive surgical technique with partial removal of granulation tissue | Experimental | Minimally invasive surgical technique with partial removal of granulation tissue Receives: Procedure: minimally invasive surgical technique with granulation tissue preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
measured from cemento-enamel junction to the base of the pocket by using william's graduated periodontal probe
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 May 2023
- Primary completion5 Mar 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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
- 1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yomna Medhat Elsaka, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591416
- Sponsor's protocol ID
- MIST
- Status last verified
- Apr 2023
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgical Technique with and Without Granulation Tissue Preservation Using a Combination of Β Tri-Calcium Phosphate and Hyaluronic Acid Gel
- ClinicalTrials.gov ID
- NCT06591416
- Acronym / sponsor ID
- MIST
- Conditions
- Periodontal Diseases
- Keywords
- Minimally invasive surgical technique, Granulation tissue preservation, infrabony defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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.
In the fast-growing era of contemporary periodontology, the understanding of biological concepts in wound healing together with the evolution of the flap design and biomaterials applied in periodontal regeneration allowed for improved minimally invasive surgical techniques. As minimally invasive approaches reduce the surgical trauma, maintain soft tissue support which allow stable primary closure of the wound. These advantages have led more researchers to apply the concept of minimally invasive surgical techniques (MISTs) in the treatment of infrabony lesions.
Granulation tissue is an immature connective tissue that appears naturally during chronic inflammation or wound healing. This tissue is not a cause of periodontitis.
So, no need to remove it during periodontal treatment. The aim of preservation of the defect-filling granulation tissue after detachment of its base is assumed to act as a soft tissue support, and to increase wound stability especially in the area of the interdental papilla and avoid post-operative marginal recession. One of the alloplastic bone grafts is βeta tri-calcium phosphate (β-TCP). β-TCP has been widely used in periodontal regeneration, where many studies used beta tri-calcium phosphate alone or in combination with other grafting materials in different surgical regenerative procedures have shown promising results for bone filling and new vital bone formation. Hyaluronic acid gel shows anti-inflammatory, antibacterial, and antioxidant properties in the treatment of periodontal diseases. In addition, due to its viscoelastic properties, it can be used as an adjunct to maintain space during periodontal tissue regeneration.
A concentration of 0.8% hyaluronic acid gel has been used effectively in the non-surgical and surgical management of periodontal diseases.
Aim of The Study The aim of the present study is to evaluate the effects of the minimally invasive surgical technique with and without granulation tissue preservation using a combination of beta tri calcium phosphate and hyaluronic acid gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgical technique with total removal of granulation tissue | Active comparator | Procedure: minimally invasive surgical techniqueMinimally invasive surgical technique with total removal of granulation tissue |
| Minimally invasive surgical technique with partial removal of granulation tissue | Experimental | Procedure: minimally invasive surgical technique with granulation tissue preservationMinimally invasive surgical technique with partial removal of granulation tissue |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient age ranged from 30 to 50 years old for both genders.
- Patients are medically free according to the American society of anesthesiologists (ASA) considered as ASA I.
- The selected participants with a diagnosis stage III grade B periodontitis.
- Defect morphology: Isolated interproximal infrabony defect of at least 5mm CAL which does not extend beyond the adjacent interproximal region.
- Optimal compliance as assessed during the case related phase I therapy and evidenced by no missed treatment appointments and positive attitude toward oral hygiene.
Key exclusion criteria (6 listed)
- Smoker and pregnant patients.
- Multiple, interconnected vertical defects.
- Generalized horizontal bone defects.
- Teeth with incorrect endodontic treatment or restoration.
- Stage I, II or IV periodontitis.
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 |
|---|---|---|
| minimally invasive surgical techniqueminimally invasive surgical technique | Procedure or surgery | Minimally invasive surgical technique with total removal of granulation tissue |
| minimally invasive surgical technique with granulation tissue preservationminimally invasive surgical technique with granulation tissue preservation | Procedure or surgery | Minimally invasive surgical technique with partial removal of granulation tissue |
Primary outcome
Clinical attachment level
Time frame: 6 months
measured from cemento-enamel junction to the base of the pocket by using william's graduated periodontal probe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive surgical technique and minimally invasive surgical technique with granulation tissue preservation in people with Periodontal Diseases, run by Misr University for Science and Technology at 1 site in Egypt.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level (time frame: 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 19 Sep 2024.