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The Use of Chlorhexidine Gel Following EDTA Root Surface Etching as an Adjunctive to Open Flap Debridement in Treating Intra-Bony Defects

10 de diciembre de 2021 actualizado por: Ain Shams University

The Use of Chlorhexidine Gel Following EDTA Root Surface Etching as an Adjunctive to Open Flap Debridement in Treating Intra-Bony Defects.

SUMMARY Chronic periodontitis is regarded as an inflammatory disease that affects the supporting tissues of teeth which could lead to bone destruction. According to the pattern of bone destruction, vertical infrabony defect could occur. Several biomaterials have been used to treat infrabony defects including bone grafts, membranes, anti-microbials, growth factor & Enamel matrix proteins. CHX gel which has been widely used in the treatment of infra-bony defects.

Chemical treatment of root surfaces of teeth have been used as an adjunct with mechanical instrumentation. Among these chemical agents is EDTA which was found to be able to remove the smear layer and expose the collagen fibers on the root surface which would make the root surface biocompatible favoring fibroblast attachment and increase substantivity of CHX gel. However, studies have found that there was no clinical significance of EDTA with chlorhexidine gel .

Recent studies revealed that significant improvements could be obtained for deep intrabony defects after EDTA root surface etching and CHX gel application after non-surgical therapy compared to control non etched treated sites. This could be attributed to the associated prolonged and higher values of CHX levels for the CHX-EDTA-treated group. However, the main target of that work is to quantify levels of CHX during the early stages of healing to determine if such clinical improvement could be attributed to prolonged and increased CHX levels after EDTA root surface preconditioning.

The aim of this study was to evaluate clinically the use of Chlorhexidine gel following root surface EDTA after open flap debridement in treating Intra-bony defects and to study the effect of EDTA bone etching on Bone Morphogenetic Protein-2 (BMP-2) in gingival crevicular fluid.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

SUBJECTS AND METHODS A total of 20 patients were selected from the outpatient clinic of Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University. The proposal reviewed by the research ethics committee, Faculty of Dentistry, Ain-shams University.

Patients fulfilling the inclusion criteria were randomly divided into one of two groups using a randomizing program (Randomization.com):

Group 1:

This group included 10 patients with localized periodontitis stage 2 or 3, grade A infra-bony defect sites (Caton, 2018) that had undergone proper curettage ensuring complete removal of all granulation tissue present within the defect by sub-mechanical debridement then open flap debridement only.

Group 2:

This group included 10 patients with localized periodontitis stage 2 or 3, grade A infra-bony defect sites (Caton, 2018) that had undergone proper curettage ensuring complete removal of all granulation tissue present within the defect by sub-mechanical debridement then open flap debridement before treating root and bony walls of the pocket surfaces by application of 24% EDTA etching and washing with saline, then application of 2% chlorhexidine gel on root surface.

Inclusion criteria:

  1. Age from 32 to 60 years old.
  2. Females and males.
  3. Healthy adult patients.
  4. Selected patient with a single site of defect:

Two walled defect or three walled infra-bony defect. The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.

Pocket depth of more than or equal to 5 mm. Clinical attachment loss equal or more than 3mm.

Exclusion criteria:

  1. Smokers.
  2. Breast feeding and pregnant females.
  3. Vulnerable group of patients (handicapped and prisoners).
  4. Patients who have received any periodontal therapy or antibiotics in the last 6 months.

The study protocol explained in details to all patients. Then a signed informed consent obtained from the patients. The data obtained from patients as well as the results of the follow up will be kept confidential.

Measurements and indices:

Clinical Assessment were done using Universal Dental Williams Michigan Probe.

The following clinical parameters were measured in every patient before the surgery and after 3 months of the surgery:

Initial therapy by full mouth supra and sub-gingival mechanical debridement using ultrasonic scaler and hand instruments have been done on all patients. The patients were given instructions for self-performed plaque control measures with soft dental brush and interdental cleaning using dental floss or interdental brush to achieve good oral hygiene. All groups were subjected to the previous procedure. All groups received open flap debridement after one month of scaling and root planning.

Open flap debridement initiated by giving infiltration local anesthesia (Articaine Hydrochloride 4% and Epinephrine 1:100,000) to the affected area. Then a reverse bevel incision and full thickness flaps were elevated. This helped to gain access for deep scaling, root planning and removal of granulation tissues and tissue tags and irrigation into the pockets.

Baseline samples from the gingival crevicular fluid were collected from all selected sites using filter paper inserted into the deepest part of each periodontal pocket and left in situ for 30 seconds for assessment of BMP-2 concentrations.

In both groups, the area of selected pocket were completely dried using oil free air syringe, and then the site was isolated with cotton rolls to prevent contamination from saliva.

The local drug delivery gel (24% of EDTA gel on root and bone surface and then application of 2% of chlorhexidine gel on root surface) were placed for group 2 in the periodontal pockets using a dedicated syringe until the gel flowed out from the gingival margin for 1 minute. Filter paper were inserted into the orifice of the pocket for 1 minute. This was done in the day of surgery then after 3 days, 7 days, 14 days and 21 days after the local drug delivery to measure the gel release profile. (Ahmed Y. Gamal and Jason M. Mailhot, 2007).

The flaps were replaced as close as possible to their original position and sutured by polypropylene (4-0) suture with interrupted interproximal sutures to achieve as complete coverage of the inter-dental areas as possible.

- Poste-operative care: All patients received amoxicillin antibiotic three times per day. Patients were also prescribed 0.12% chlorhexidine digluconate mouthwash (Hexitol antiseptic mouthwash, Arab Drug Company, Egypt) to be used twice per day for one week and were instructed to avoid brushing at the site of surgery for the first ten days. Sutures were removed after 1 week and then application of perio- pack for another 1 week and follow up after 3 months.

6) Biochemical assessment: i. EDTA and Chlorhexidine gel release profile: The collected samples were labeled and carried in a dark container until High Performance Liquid Chromatography (HPLC) evaluation.

ii. Concentration of BMP-2: In both groups, assessment was done at baseline and one month after local drug delivery.

BMP-2 concentrations were determined using a commercial human BMP-2 ELISA Kit. Measurements were performed according to the manufacturer's instructions.

Measurement of BMP-2 in GCF by ELISA:

GCF was extracted from the filter paper after addition of 100ul of PBS (pH 7) and centrifugation at 5000xg. The supernatant was used for measurement of the BMP-2. The kit was provided by Chongqing Biospes Co., Ltd, China (Catalog No.: BEK1014)

Tipo de estudio

Intervencionista

Inscripción (Actual)

20

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

32 años a 60 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

  1. Age from 32 to 60 years old.
  2. Females and males.
  3. Healthy adult patients.
  4. Selected patient with a single site of defect in single tooth:

Two walled or three walled infra-bony defect. The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.

Pocket depth of more than or equal to 5 mm. Clinical attachment loss equal or more than 3mm.

Exclusion criteria:

  1. Smokers.
  2. Breast feeding and pregnant females.
  3. Vulnerable group of patients (handicapped and prisoners).
  4. Patients who have received any periodontal therapy or antibiotics in the last 6 months.

The study protocol explained in details to all patients. Then a signed informed consent obtained from the patients. The data obtained from patients as well as the results of the follow up will be kept confidential.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: open flap + mechanical debridement
This group included 10 patients with periodontitis stage 2 or 3, grade A infra-bony defect sites (Caton, 2018) that had undergone proper curettage ensuring complete removal of all granulation tissue present within the defect by scaling and root planning then open flap debridement only.
Experimental: open flap +CHX gel 2 % + 24% EDTA
This group included 10 patients with periodontitis stage 2 or 3, grade A infra-bony defect sites (Caton, 2018) that had undergone proper curettage ensuring complete removal of all granulation tissue present within the defect by scaling and root planning then open flap debridement before treating root and bony walls of the pocket surfaces by application of 24% EDTA etching and washing with saline, then application of 2% chlorhexidine gel on root surface.
The local drug delivery gel (24% of EDTA gel on root and bone surface and then application of 2% of chlorhexidine gel on root surface) were placed for group 2 in the periodontal pockets Filter paper were inserted into the orifice of the pocket for 1 minute. This was done in the day of surgery then after 3 days, 7 days, 14 days and 21 days after the local drug delivery to measure the gel release profile.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
bleeding on probing
Periodo de tiempo: 3 months
Williams graduated periodontal probe using bleeding index
3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Bone Morphogenetic Protein-2 (BMP-2)
Periodo de tiempo: 3 months
by Elissa kit release profile in gingival crevicular fluid.
3 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
radiographic X ray
Periodo de tiempo: 3 months
long parallel technique
3 months
Clinical attachment loss
Periodo de tiempo: 3 months
Williams graduated periodontal probe
3 months
probing depth
Periodo de tiempo: 3 months
Williams graduated periodontal probe
3 months
plaque
Periodo de tiempo: 3 months
plaque index using Williams graduated periodontal probe
3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2017

Finalización primaria (Actual)

1 de enero de 2018

Finalización del estudio (Actual)

1 de mayo de 2018

Fechas de registro del estudio

Enviado por primera vez

16 de agosto de 2021

Primero enviado que cumplió con los criterios de control de calidad

10 de diciembre de 2021

Publicado por primera vez (Actual)

28 de diciembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de diciembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

10 de diciembre de 2021

Última verificación

1 de febrero de 2017

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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