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Comparative Evaluation of Buccal Fat Pad and Subepithelial Connective Tissue Graft (RCT)

30. januar 2022 oppdatert av: shehad wael, Ain Shams University

Comparative Evaluation of Buccal Fat Pad and Subepithelial Connective Tissue Graft in the Treatment of Localized Recession (Randomized Clinical Trial)

Compare between Buccal fat pad and subepithelial connective tissue graft in treatment of localized recession.

Primary objective: to evaluate root coverage in terms of gingival thickness and esthetic.

Secondary objective: to evaluate patient satisfaction and postoperative pain.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Material and Methods

16 patients from outpatient Oral Diagnosis dental clinic will participate in this study.

Patient selection and hospitalization

Prospective randomized clinical trial will be conducted on patients requiring correction of gingival recession. The research will be reviewed by the ethical committee of Faculty of Dentistry Ain Shams University.

Patient Grouping

Patient will be randomly allocated into one of the two groups:

control group (8 patients): will be treated with coronally advanced flap combined with subepithelial Connective tissue graft (SCTG).

Study group(8 patients): will be treated with coronally advanced flap combined with buccal fat pad (BFP).

Preoperative Assessment

For all patients routine radiographic investigations are required. The first phase of therapy formed of oral hygiene measures, scaling, subgingival debridement and correction of any disturbance in occlusion needed. A periodontal evaluation should be done two weeks after phase I therapy.

A stent will be made for each defect with vertical groove located at the mid-labial region to standardize the placement and angulation of probe while taking measurement. All measurements will be taken with a standardized Williams graduated periodontal probe (Hu-Friedy).

Surgical procedure:

  • Oral antiseptic mouthwash will be used before anaesthetizing the surgical area. A field block anesthesia at the surgical area is given with a lidocaine and epinephrine-containing solution.

    a) Recipient site preparation

  • A split-thickness flap will be reflected by a horizontal incision made at the papilla base, mesial and distal to the recession defects. Two slightly divergent incisions will be released from the end of the previous horizontal incisions with a full-thickness flap starting from margin of the gingiva reaching 3-4 mm after the exposed bone then continue with a split-thickness extending to the alveolar mucosa .
  • After flap elevation scaling, planing of the exposed root followed by root conditioning with a tetracycline solution (125 mg tetracycline/ml of saline). In the study group sites, previously prepared BFP or a subepihelial CT graft in control group will be applied over the exposed root a single sling suture will fix the flap just coronal to the Cemento-enamel junction (CEJ). Flaps will also be coronally positioned.

    b) Donor site:

  • In study group the buccal vestibule is anesthetized in vicinity of the first and second maxillary molar. The cheek will be retracted laterally and a mucosal incision will be made while leaving a cuff of non- attached mucosa for closure. The incision will be done throughout the mucosa and muscle meanwhile an external pressure will be applied on the skin in the area of the buccal fat pad. After the buccal fat pad exposure, the fascia is pierced with scissors. With a continuous external pressure on the cheeck a long hemostat is used to spread and manipulate the fat. With minimal delicate traction, the protruding portion of the fat pad is gently grasped and pulled outside of the incision then the fat is clamped at the base and the required amount is harvested and excised to be used in donor site. The incision is closed with suture .
  • The control group will receive SCTG from the palate with a single incision technique .

Postoperatively patients will be covered by Augmentine 1 gm tablets every 12 hours and flagyl 500 mg every eight hours. Analgesics are given in a combined protocol; where ibuprofen 600mg and paracetamol 1gm are alternating. The patient is instructed to use 0.12% chlorhexidine mouthwash three times daily for two weeks.

Methods of assessment

The parameters which should be measured at baseline, 3 and 6 months after surgery:

  1. Plaque index (PI) will be recorded according to Silness and Loe .
  2. Gingival index (GI) will be recorded according to Loe and Silness .
  3. Probing depth (PD).
  4. Clinical attachment level (CAL).
  5. Recession depth (RD).
  6. Recession width (RW).
  7. Percentage of mean root coverage (MRC %) will be calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.
  8. Width of keratinized tissue (WKT).
  9. Gingival thickness (GTH).
  10. Root coverage esthetic score (RES).
  11. Pain level will be assessed by verbal, numeric scale and by recording amount of analgesic intake postoperatively.

Result presentation and statistics

Results will be tabulated and statistically analyzed.

Studietype

Intervensjonell

Registrering (Faktiske)

16

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Cairo, Egypt, 11757
        • Ain Shams University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients should be above 18 years.
  • Patient included in the study will be with Miller class II recession defect.
  • Patient having at least 1 mm of residual keratinized tissue.

Exclusion Criteria:

  • Patient with Systemic Problem affecting the results of periodontal Therapy.
  • Patients having allergy to drugs.
  • Pregnant women.
  • Patients with any smoking habits.
  • Patients having bleeding problems or on anticoagulant therapy.
  • Patients having caries or restorations in relation to the treated site.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: study group
Use of free fat graft to cover exposed root
fat harvested from patient will be used to cover exposed root
Aktiv komparator: control group
use of sub epithelial connective tissue graft to cover exposed root
subepitheial graft harvested from palate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
evaluation of root coverage esthetic score
Tidsramme: 6 months
evaluation of root gingival coverage after modified Coronally advanced flap the scale is from 1-4 ... based on degree of coverage the score will be given 1=1005, 2=75%, 3=50%, 4=25%
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: shehad wael, Ain Shams University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. juni 2018

Primær fullføring (Faktiske)

24. januar 2021

Studiet fullført (Faktiske)

24. januar 2021

Datoer for studieregistrering

Først innsendt

31. mars 2021

Først innsendt som oppfylte QC-kriteriene

16. april 2021

Først lagt ut (Faktiske)

19. april 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. januar 2022

Sist bekreftet

1. januar 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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