How Can Prefabricated Membranes Load Ascorbic Acid Can Curtail Gingival Recession? (recession)

April 17, 2025 updated by: shaimaa hamdy, Minia University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: shaimaa Hamdy, lecturer of Periodontology
  • Phone Number: +201555035523 +201030576405
  • Email: shimaa.3m.sh@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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. Teeth exhibiting pathologic mobility.
  3. Mal alignment teeth.
  4. Patients under active orthodontic therapy.
  5. Periodontal therapy during the last 6 months.
  6. Patients received antibiotics or non-steroidal anti-inflammatory drugs six months before the beginning of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: control group
Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with a placebo membrane
Drug: Ascorbic acid
Ascorbic acid induce gingival healing
Active Comparator: study group
Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with membrane loaded by Ascorbic acid
Drug: Ascorbic acid
Ascorbic acid induce gingival healing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gingival recession height
Time Frame: baseline, 3months and 6 months
The distance from the cementoenamel junction to the gingival margin
baseline, 3months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • gingival recession treatment
  • committe no 109 (Other Identifier: faculty of dentistry minia university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

after study acceptance for journal all data about the study will be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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