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Evaluation of two chemical agents in gingival graft surgeries

Comparative clinical evaluation of the use of Chlorexidine and Phthalocyanine in the postoperative of Subepithelial Connective Tissue Graft

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-93ccq38
Enrollment
Unknown
Registered
2023-08-14
Start date
2023-04-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival recession

Interventions

The study is a randomized controlled, split-mouth clinical trial. Patients will be randomly assigned to one of the two groups below:Group CHX: use of the toothpaste (Zinc Citrate 2%
Pyrophosphate and Sodium Fluoride 1,450 ppm) and rinse (chlorhexidine gluconate 0.12%). PHY group: use of the dental gel and topical gel of Phthalocyanine (0.1%) Both groups will use the agents for th
root surfaces without abrasion, erosion or caries, systemically healthy patients, without contraindication for periodontal surgical procedures. Exclusion criteria will be: rotated, extruded, or comorb

Sponsors

Universidade de São Paulo
Lead Sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients of both genders; aged between 18 and 70 years old; clinical diagnosis of multiple gingival recessions RT1 with at least 1 gingival recession = 2 mm, including canines and premolars; root surfaces without abrasion, erosion, or caries; systemically healthy patients; no contraindication for periodontal surgical procedures.

Exclusion criteria

Exclusion criteria: Rotated teeth; extruded or mobile teeth; smokers; pregnant and lactating individuals; history of periodontal disease or recurrent abscess formation; patients previously undergone root coverage surgical procedures; patients using medications [anticonvulsants, antihypertensives, contraceptives, or immunosuppressants]; low level of oral hygiene (plaque index and bleeding index >20%)

Design outcomes

Primary

MeasureTime frame
Evaluating the remaining wound area (RWA) will be considered the primary outcome variable. The method for assessment will be performed using Image J software - NIH, Bethesda, USA. A minimum detectable difference of 30% in the remaining wound area (WRA) and a standard deviation of 5 mm² were assumed

Secondary

MeasureTime frame
The thickness of the palatal masticatory mucosa will be evaluated under anesthesia before the procedure and 2 months after the procedure through four fixed points (at 5 and 7 mm from the gingival margin) in the donor area. A guide will be made to standardize the points to be measured. ET will be measured using a periodontal probe with an endodontic stop at the 4 marked points until touching the palatal bone tissue. The distance between the stop and the tip of the probe will be measured in millimeters using a digital caliper

Countries

Brazil

Contacts

Public ContactMariana Calefi

Universidade de São Paulo

mariana.calefi@usp.br+55 (14) 3235-8278

Outcome results

None listed

Source: REBEC (via WHO ICTRP)