Gingival Recession, LocalizedrecessionNCT06936592
How Can Prefabricated Membranes Load Ascorbic Acid Can Curtail Gingival Recession?
A study testing Ascorbic acid in people with Gingival Recession, Localized and Gingival Diseases, run by Minia University.
Trial summary
Periodontal diseases are a prevalent issue, often leading to gingival recession, where the gingival margin recedes, exposing the tooth root and causing various problems. Gingival recession can be managed through both non-surgical and surgical interventions The non-surgical approach often involves plaque control and… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Gingival Recession, Localized, Gingival Diseases, Recession, Gingival
- What is being tested?
- Ascorbic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2025to 18 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
- Patients of both genders with ages more than 18 years.
- At least two adjacent teeth in maxillary or mandibular anterior sextant with Cairo classification (RT1 or RT 2) labial GR defect.
- Good general health with no contraindications for periodontal surgery (American Society of Anesthesiologists I).
- Non-smoker patients.
Who cannot join
- Pregnant and lactating women.
- Teeth exhibiting pathologic mobility.
- Mal alignment teeth.
- Patients under active orthodontic therapy.
- Periodontal therapy during the last 6 months.
- 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: How Can Prefabricated Membrane-loaded Ascorbic Acid Curtail the Gingival Recession?
Periodontal diseases are a prevalent issue, often leading to gingival recession, where the gingival margin recedes, exposing the tooth root and causing various problems. Gingival recession can be managed through both non-surgical and surgical interventions The non-surgical approach often involves plaque control and addressing any underlying inflammatory conditions. However, in cases of advanced recession, surgical treatment may be necessary Several treatment techniques have been proposed, which can be divided into pedicle and free grafts. The latter can also be classified as free gingival grafts (FGG) or as connective tissue grafts (CTG). Other treatment options include soft tissue substitutes or regenerative therapies Harvesting graft from the palate has several problems, such as pain, inflammation, bleeding, flap necrosis, and infection at the donor site. For this reason, we need a substitute for soft tissue graft harvesting Carbopol polymers, also known as carbomers, are widely utilized in pharmaceutical formulations for their excellent mucoadhesive properties. This high molecular weight, cross-linked acrylic acid polymers are particularly effective in enhancing the adhesion of formulations to mucosal surfaces, thereby improving drug delivery and bioavailability
Read the detailed description
Gingival recession is a common finding in daily clinical practice. Several issues may be associated with the apical shift of the gingival margin such as dentine hypersensitivity, root caries, non-carious cervical lesions (NCCLs), and compromised aesthetics. The first step in an effective management and prevention program is to identify susceptibility factors and modifiable conditions associated with gingival recession. Non-surgical treatment options for gingival recession defects include establishing optimal plaque control, removing overhanging subgingival restorations, behavior change interventions, and using desensitizing agents. In cases where a surgical approach is indicated, coronally advanced flap and tunneling procedures combined with a connective tissue graft are considered the most predictable treatment options for single and multiple recession defects. If there is a contraindication for harvesting a connective tissue graft from the palate or the patient wants to avoid a donor site surgery, adjunctive use of acellular dermal matrices, collagen matrices, and/or enamel matrix derivatives can be a valuable treatment alternative. For gingival recession defects associated with NCCLs a combined restorative-surgical approach can provide favourable clinical outcomes. If a patient refuses a surgical intervention or there are other contraindications for an invasive approach, gingival conditions should be maintained with preventive measures. This paper gives a concise review of when and how to treat gingival recession defects.
- Being tested
- Ascorbic acid
- Keywords
- recession, membrane, ascorbic acide, graft
- Medical subject headings
- Gingival Recession, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Ascorbic acid induce gingival healing
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with a placebo membrane Receives: Drug: Ascorbic acid |
| study group | Active comparator | Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with membrane loaded by Ascorbic acid Receives: Drug: Ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival recession height
The distance from the cementoenamel junction to the gingival margin
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 start17 Apr 2025 (estimated)
- Primary completion17 Oct 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies 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
- Inclusion criteria: 1. Patients of both genders with ages more than 18 years. 2. At least two adjacent teeth in maxillary or mandibular anterior sextant with Cairo classification (RT1 or RT 2) labial GR defect. 3. Good general health with no contraindications for periodontal surgery (American Society of Anesthesiologists I). 4. Non-smoker patients. Exclusion criteria: 1. Pregnant and lactating women. 2. Mal alignment teeth. 3. Patients under active orthodontic therapy. 4. Periodontal therapy during the last 6 months. Groups and intervention: Patients selected in this study will be classified into two groups: • Group 1: Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with a placebo membrane
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- NCT06936592
- Sponsor's protocol ID
- gingival recession treatment
- Other IDs
- committe no 109
- Acronym
- recession
- 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 study acceptance for journal all data about the study will be available
Publications
Imber JC, Kasaj A. Treatment of Gingival Recession: When and How? Int Dent J. 2021 Jun;71(3):178-187. doi: 10.1111/idj.12617. Epub 2021 Jan 29.
PubMed 34024328
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
- How Can Prefabricated Membrane-loaded Ascorbic Acid Curtail the Gingival Recession?
- ClinicalTrials.gov ID
- NCT06936592
- Acronym / sponsor ID
- recession / gingival recession treatment
- Keywords
- recession, membrane, ascorbic acide, graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (estimated)
- Primary completion
- 17 Oct 2025 (estimated)
- Study completion
- 18 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 diseases are a prevalent issue, often leading to gingival recession, where the gingival margin recedes, exposing the tooth root and causing various problems. Gingival recession can be managed through both non-surgical and surgical interventions The non-surgical approach often involves plaque control and addressing any underlying inflammatory conditions. However, in cases of advanced recession, surgical treatment may be necessary Several treatment techniques have been proposed, which can be divided into pedicle and free grafts. The latter can also be classified as free gingival grafts (FGG) or as connective tissue grafts (CTG). Other treatment options include soft tissue substitutes or regenerative therapies Harvesting graft from the palate has several problems, such as pain, inflammation, bleeding, flap necrosis, and infection at the donor site. For this reason, we need a substitute for soft tissue graft harvesting Carbopol polymers, also known as carbomers, are widely utilized in pharmaceutical formulations for their excellent mucoadhesive properties. This high molecular weight, cross-linked acrylic acid polymers are particularly effective in enhancing the adhesion of formulations to mucosal surfaces, thereby improving drug delivery and bioavailability
Detailed description
Gingival recession is a common finding in daily clinical practice. Several issues may be associated with the apical shift of the gingival margin such as dentine hypersensitivity, root caries, non-carious cervical lesions (NCCLs), and compromised aesthetics. The first step in an effective management and prevention program is to identify susceptibility factors and modifiable conditions associated with gingival recession. Non-surgical treatment options for gingival recession defects include establishing optimal plaque control, removing overhanging subgingival restorations, behavior change interventions, and using desensitizing agents. In cases where a surgical approach is indicated, coronally advanced flap and tunneling procedures combined with a connective tissue graft are considered the most predictable treatment options for single and multiple recession defects. If there is a contraindication for harvesting a connective tissue graft from the palate or the patient wants to avoid a donor site surgery, adjunctive use of acellular dermal matrices, collagen matrices, and/or enamel matrix derivatives can be a valuable treatment alternative. For gingival recession defects associated with NCCLs a combined restorative-surgical approach can provide favourable clinical outcomes. If a patient refuses a surgical intervention or there are other contraindications for an invasive approach, gingival conditions should be maintained with preventive measures. This paper gives a concise review of when and how to treat gingival recession defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Inclusion criteria: 1. Patients of both genders with ages more than 18 years. 2. At least two adjacent teeth in maxillary or mandibular anterior sextant with Cairo classification (RT1 or RT 2) labial GR defect. 3. Good general health with no contraindications for periodontal surgery (American Society of Anesthesiologists I). 4. Non-smoker patients. Exclusion criteria: 1. Pregnant and lactating women. 2. Mal alignment teeth. 3. Patients under active orthodontic therapy. 4. Periodontal therapy during the last 6 months. Groups and intervention: Patients selected in this study will be classified into two groups: • Group 1: Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with a placebo membrane
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Ascorbic acidFifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with a placebo membrane |
| study group | Active comparator | Drug: Ascorbic acidFifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with membrane loaded by Ascorbic acid |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of both genders with ages more than 18 years.
- At least two adjacent teeth in maxillary or mandibular anterior sextant with Cairo classification (RT1 or RT 2) labial GR defect.
- Good general health with no contraindications for periodontal surgery (American Society of Anesthesiologists I).
- Non-smoker patients.
Key exclusion criteria (6 listed)
- Pregnant and lactating women.
- Teeth exhibiting pathologic mobility.
- Mal alignment teeth.
- Patients under active orthodontic therapy.
- Periodontal therapy during the last 6 months.
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 |
|---|---|---|
| Ascorbic acidAscorbic acid induce gingival healing | Drug | control group, study group |
Primary outcome
Gingival recession height
Time frame: baseline, 3months and 6 months
The distance from the cementoenamel junction to the gingival margin
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.
- Background: PubMed 34024328Imber JC, Kasaj A. Treatment of Gingival Recession: When and How? Int Dent J. 2021 Jun;71(3):178-187. doi: 10.1111/idj.12617. Epub 2021 Jan 29.
- Treatment of Gingival Recession: When and How?Link provided by the sponsor.
- Individual participant dataSharing planned: No. after study acceptance for journal all data about the study will 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 Ascorbic acid in people with Gingival Recession, Localized and Gingival 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 4 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: 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?
Gingival recession height (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?
On the ClinicalTrials.gov record for NCT06936592, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 29 Oct 2026.