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Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects

17. august 2026 oppdatert av: Vy Truong Tuong Huynh, University of Medicine and Pharmacy at Ho Chi Minh City

Efficacy of Enamel Matrix Derivative Combined With Xenograft in the Treatment of Furcation Defects in Mandibular Molars

This randomized controlled clinical trial aims to compare two regenerative surgical approaches for the treatment of mandibular molar Class II furcation defects in patients with periodontitis. Eligible furcation defects will be randomly assigned to receive either xenograft bone combined with enamel matrix derivative (EMD) or xenograft bone combined with a collagen membrane. Both approaches are used to support periodontal tissue regeneration.

Participants will be followed for approximately 7 months. The study will evaluate postoperative pain and patient-reported satisfaction, periodontal clinical parameters, changes in furcation defect volume and relative bone density on cone-beam computed tomography (CBCT), and changes in gingival crevicular fluid TWEAK levels. Clinical and radiographic outcomes will be assessed before surgery and during follow-up, including at 3 and 6 months after surgery.

The study is intended to determine whether xenograft bone combined with EMD provides clinical, radiographic, biological, and patient-reported outcomes comparable or superior to xenograft bone combined with a collagen membrane in the regenerative treatment of mandibular molar Class II furcation defects.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized controlled clinical trial involving patients with periodontitis who have Class II furcation defects affecting mandibular first and/or second molars. A total of 24 eligible teeth are planned, with 12 teeth assigned to each treatment group.

Before surgery, participants will undergo clinical periodontal examination, intraoral three-dimensional scanning, CBCT imaging, and gingival crevicular fluid collection. Clinical measurements include plaque index (PI), gingival index (GI), probing pocket depth (PPD), vertical clinical attachment loss (VCAL), and horizontal clinical attachment loss (HCAL).

Eligible defects will be randomly assigned to one of two regenerative surgical treatments. Following flap elevation, debridement, root surface cleaning, and conditioning with 24% EDTA, the control group will receive xenograft bone covered with a resorbable collagen membrane. The experimental group will receive enamel matrix derivative applied to the defect-related root surface, followed by xenograft bone combined with enamel matrix derivative. The flap will then be repositioned and sutured.

Postoperative pain will be assessed using a visual analog scale, together with analgesic consumption and patient-reported satisfaction regarding swelling and chewing ability. Participants will return for follow-up at approximately 2 weeks, 1 month, 3 months, and 6 months after surgery. Gingival crevicular fluid will be collected during follow-up for measurement of TWEAK concentration.

At 3 months, selected periodontal and biological assessments will be repeated. At 6 months, periodontal clinical measurements, intraoral three-dimensional scanning, furcation defect classification, and CBCT imaging will be repeated to evaluate changes in defect volume and relative bone density.

The primary purpose of the study is to compare the regenerative effectiveness of xenograft bone combined with enamel matrix derivative with that of xenograft bone combined with a collagen membrane for the treatment of mandibular molar Class II furcation defects.

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Vietnam
    • Binh Phu
      • Ho Chi Minh City, Binh Phu, Vietnam, 700000
        • Rekruttering
        • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
        • Ta kontakt med:

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older.
  • Full-mouth plaque score (FMPS) ≤ 20%.
  • Full-mouth bleeding score (FMBS) ≤ 20%.
  • Willingness to participate in the study and provide informed consent.
  • Mandibular first and/or second molar with a buccal Class II furcation defect classified as subgroup A2 or B2.
  • Probing pocket depth (PPD) ≥ 5 mm at the eligible furcation site.
  • Keratinized gingival height ≥ 2 mm at the eligible site.
  • No gingival recession extending apically beyond the buccal furcation roof; the furcation entrance must not be clinically exposed above the gingival margin.

Exclusion Criteria:

  • Systemic diseases or conditions that may affect periodontal treatment outcomes, including uncontrolled diabetes mellitus, heart disease requiring anticoagulant therapy, hematologic disorders, or immunodeficiency.
  • Pregnancy or breastfeeding.
  • Untreated endodontic pathology involving the study tooth.
  • Class III furcation involvement according to the Hamp classification.
  • Untreated occlusal trauma involving the study tooth.
  • Grade II tooth mobility that has not been stabilized by splinting, or Grade III tooth mobility according to the Miller classification.
  • Defective restorations at the surgical site, including overhanging, bulky, or poorly adapted restorations.

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: Xenograft + Enamel Matrix Derivative
Fremgangsmåte: Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative
Periodontal regenerative surgery is performed using xenograft bone combined with enamel matrix derivative (EMD). After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, EMD is applied to the root surface associated with the furcation defect. The xenograft bone is mixed with EMD and placed to completely fill the defect. The flap is then repositioned and sutured.
Aktiv komparator: Xenograft + Collagen Membrane
Fremgangsmåte: Periodontal Regenerative Surgery With Xenograft and Collagen Membrane
Periodontal regenerative surgery is performed using xenograft bone combined with a resorbable collagen membrane. After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, the xenograft bone is mixed with sterile saline and placed to completely fill the furcation defect. A trimmed resorbable collagen membrane is positioned to completely cover the defect and secured before flap repositioning and suturing.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Probing Pocket Depth (PPD)
Tidsramme: Baseline and 6 months after surgery
Probing pocket depth (PPD) is measured in millimeters from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at the mesiobuccal, buccal, and distobuccal sites of the treated tooth. Measurements are standardized using an individualized acrylic stent. The change in PPD from baseline to 6 months after surgery will be compared between the two treatment groups.
Baseline and 6 months after surgery
Change in Horizontal Clinical Attachment Loss (HCAL)
Tidsramme: Baseline and 6 months after surgery
Horizontal clinical attachment loss (HCAL) is measured in millimeters from the buccal entrance of the furcation to the deepest horizontal point of the furcation defect using a Nabers periodontal probe and an individualized acrylic stent.
Baseline and 6 months after surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Vertical Clinical Attachment Loss (VCAL)
Tidsramme: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Buccal Gingival Recession (REC)
Tidsramme: Baseline, 3 months, and 6 months after surgery
Baseline, 3 months, and 6 months after surgery
Change in Plaque Index (PI)
Tidsramme: Baseline, 3 months, and 6 months after surgery
Baseline, 3 months, and 6 months after surgery
Change in Gingival Index (GI)
Tidsramme: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Furcation Defect Volume on CBCT
Tidsramme: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Relative Bone Density on CBCT
Tidsramme: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Gingival Crevicular Fluid TWEAK Concentration
Tidsramme: Baseline, 1 month, and 3 months after surgery
Baseline, 1 month, and 3 months after surgery
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Tidsramme: 12 hours, 24 hours, and 72 hours after surgery
12 hours, 24 hours, and 72 hours after surgery
Postoperative Analgesic Consumption
Tidsramme: During the first 3 days after surgery
During the first 3 days after surgery
Patient Satisfaction With Postoperative Swelling
Tidsramme: 3 and 7 days after surgery
Patient-reported satisfaction with postoperative swelling will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate better satisfaction (better outcome).
3 and 7 days after surgery
Patient Satisfaction With Chewing Ability
Tidsramme: 3 and 7 days after surgery
Patient-reported satisfaction with chewing ability after surgery will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate better satisfaction (better outcome).
3 and 7 days after surgery

Samarbeidspartnere og etterforskere

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

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

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)

29. juni 2026

Primær fullføring (Antatt)

29. september 2027

Studiet fullført (Antatt)

30. september 2027

Datoer for studieregistrering

Først innsendt

12. august 2026

Først innsendt som oppfylte QC-kriteriene

17. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26412-ĐHYD

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