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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 dicembre 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 32 anni a 60 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
bleeding on probing
Lasso di tempo: 3 months
Williams graduated periodontal probe using bleeding index
3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bone Morphogenetic Protein-2 (BMP-2)
Lasso di tempo: 3 months
by Elissa kit release profile in gingival crevicular fluid.
3 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
radiographic X ray
Lasso di tempo: 3 months
long parallel technique
3 months
Clinical attachment loss
Lasso di tempo: 3 months
Williams graduated periodontal probe
3 months
probing depth
Lasso di tempo: 3 months
Williams graduated periodontal probe
3 months
plaque
Lasso di tempo: 3 months
plaque index using Williams graduated periodontal probe
3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2017

Completamento primario (Effettivo)

1 gennaio 2018

Completamento dello studio (Effettivo)

1 maggio 2018

Date di iscrizione allo studio

Primo inviato

16 agosto 2021

Primo inviato che soddisfa i criteri di controllo qualità

10 dicembre 2021

Primo Inserito (Effettivo)

28 dicembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 dicembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 dicembre 2021

Ultimo verificato

1 febbraio 2017

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su CHX gel 2 % + 24% EDTA

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