How Can Prefabricated Membranes Load Ascorbic Acid Can Curtail Gingival Recession?

NCT06936592 | Not Yet Recruiting

• 2 other identifiers: gingival recession treatmentcommitte no 109
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Conditions

Gingival Recession, Localized; Gingival Diseases; Recession, Gingival

Keywords

recession; membrane; ascorbic acide; graft

Outcome Measures

Primary Outcomes (1)

• Gingival recession height

  The distance from the cementoenamel junction to the gingival margin

  baseline, 3months and 6 months

Study Arms (2)

control group

PLACEBO COMPARATOR

Fifteen patients will receive Phase I therapy; reevaluation after four weeks then will be treated with a placebo membrane

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

Drug: Ascorbic acid

Interventions

Ascorbic acid DRUG

Ascorbic acid induce gingival healing

control group; study group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Related Publications (1)

• 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.

  PMID: 34024328 BACKGROUND

Related Links

• Treatment of Gingival Recession: When and How?

MeSH Terms

Conditions

Gingival Recession; Gingival Diseases

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

shaimaa Hamdy, lecturer of Periodontology

CONTACT

+201030576405; shimaa.3m.sh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants do not know the type of membrane and the outcomes assessor does not know type of group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of periodontology

Model Details: 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

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: April 17, 2025
• Primary Completion: October 17, 2025
• Study Completion: October 18, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share