Gingival RecessionNCT04980066
Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession
A study testing Sticky bone and EDTA and Sticky bone in people with Gingival Recession, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Gingival recession is a common clinical finding in periodontal disease which is frequently associated with esthetic concerns, root hypersensitivity, and root caries. Many surgical therapeutic approaches have been developed to predictably obtain root coverage of gingival recession defects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Sticky bone and EDTA and Sticky bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2021to Sep 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Miller I/II isolated maxillary recession defects.
- No abrasion, caries, or cervical restorations and presence of identifiable cementoenamel junction (CEJ).
- No occlusal interferences.
- Full-mouth plaque index (PI) and gingival index (GI) scores of < 1.
- Non-smokers.
Who cannot join
- Pregnant patients
- Presence of systemic disease or taking medication that interfere with periodontium
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
Dalia R Issa, PhD, 01007753636 ext. 002, dalia_rasheed@hotmail.com
About this study
Official title: Evaluation of Sticky Bone With or Without EDTA Root Surface Biomodification for Treatment of Gingival Recession: Randomized Controlled Clinical Study
Gingival recession is a common clinical finding in periodontal disease which is frequently associated with esthetic concerns, root hypersensitivity, and root caries. Many surgical therapeutic approaches have been developed to predictably obtain root coverage of gingival recession defects. Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent obtained by low-speed centrifugation, and it has the capacity to stimulate tissue regeneration. At high concentrations, PRF may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, with good outcomes. Ethylenediaminetetraaceti acid (EDTA) is a chelating agent that could enhance the attachment of connective tissue to the root surface by exposing collagen and, as a consequence, enhance root coverage. EDTA works at neutral pH, and this property has been reported to preserve adjacent tissue vitality. The present study will be carried out to evaluate the effect of sticky bone with or without EDTA root surface biomodification for treatment of gingival recession.
- Conditions
- Gingival Recession
- Being tested
- Sticky bone and EDTA, Sticky bone
- Keywords
- i-PRF, EDTA
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sticky bone and EDTAProcedure or surgery
treatment using Sticky bone after EDTA root surface biomodification
Sticky boneProcedure or surgery
treatment using Sticky bone
| Study group | Role | What they receive |
|---|---|---|
| sticky bone and EDTA | Experimental | treatment of gingival recession using sticky bone after root surface biomodification with EDTA Receives: Procedure: Sticky bone and EDTA |
| Sticky bone | Active comparator | treatment of gingival recession using sticky bone Receives: Procedure: Sticky bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation of root coverage
the percentage of root coverage will be calculated in millimeter
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 posted28 Jul 2021
- Study start3 Aug 2021
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Rasheed Issa, Kafrelsheikh University
- Investigators
- Dalia R Issa, PhD, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980066
- Sponsor's protocol ID
- KD/10/21
- Status last verified
- Apr 2024
- First submitted
- 24 Jun 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sticky Bone With or Without EDTA Root Surface Biomodification for Treatment of Gingival Recession: Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04980066
- Acronym / sponsor ID
- KD/10/21
- Conditions
- Gingival Recession
- Keywords
- i-PRF, EDTA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Jul 2021 (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.
Gingival recession is a common clinical finding in periodontal disease which is frequently associated with esthetic concerns, root hypersensitivity, and root caries. Many surgical therapeutic approaches have been developed to predictably obtain root coverage of gingival recession defects. Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent obtained by low-speed centrifugation, and it has the capacity to stimulate tissue regeneration. At high concentrations, PRF may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, with good outcomes. Ethylenediaminetetraaceti acid (EDTA) is a chelating agent that could enhance the attachment of connective tissue to the root surface by exposing collagen and, as a consequence, enhance root coverage. EDTA works at neutral pH, and this property has been reported to preserve adjacent tissue vitality. The present study will be carried out to evaluate the effect of sticky bone with or without EDTA root surface biomodification for treatment of gingival recession.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sticky bone and EDTA | Experimental | Procedure: Sticky bone and EDTAtreatment of gingival recession using sticky bone after root surface biomodification with EDTA |
| Sticky bone | Active comparator | Procedure: Sticky bonetreatment of gingival recession using sticky bone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Miller I/II isolated maxillary recession defects.
- No abrasion, caries, or cervical restorations and presence of identifiable cementoenamel junction (CEJ).
- No occlusal interferences.
- Full-mouth plaque index (PI) and gingival index (GI) scores of < 1.
- Non-smokers.
Key exclusion criteria (2 listed)
- Pregnant patients
- Presence of systemic disease or taking medication that interfere with periodontium
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 |
|---|---|---|
| Sticky bone and EDTAtreatment using Sticky bone after EDTA root surface biomodification | Procedure or surgery | sticky bone and EDTA |
| Sticky bonetreatment using Sticky bone | Procedure or surgery | Sticky bone |
Primary outcome
clinical evaluation of root coverage
Time frame: 6 months
the percentage of root coverage will be calculated in millimeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
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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.
Dalia R Issa, PhD principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sticky bone and EDTA and Sticky bone in people with Gingival Recession, run by Kafrelsheikh University 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 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia R Issa, PhD (01007753636 ext. 002, dalia_rasheed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical evaluation of root coverage (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 11 Apr 2024.