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Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects

17 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Geschat)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Vietnam
    • Binh Phu
      • Ho Chi Minh City, Binh Phu, Vietnam, 700000
        • Werving
        • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Xenograft + Enamel Matrix Derivative
Procedure: 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.
Actieve vergelijker: Xenograft + Collagen Membrane
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Probing Pocket Depth (PPD)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Vertical Clinical Attachment Loss (VCAL)
Tijdsspanne: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Buccal Gingival Recession (REC)
Tijdsspanne: Baseline, 3 months, and 6 months after surgery
Baseline, 3 months, and 6 months after surgery
Change in Plaque Index (PI)
Tijdsspanne: Baseline, 3 months, and 6 months after surgery
Baseline, 3 months, and 6 months after surgery
Change in Gingival Index (GI)
Tijdsspanne: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Furcation Defect Volume on CBCT
Tijdsspanne: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Relative Bone Density on CBCT
Tijdsspanne: Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Gingival Crevicular Fluid TWEAK Concentration
Tijdsspanne: Baseline, 1 month, and 3 months after surgery
Baseline, 1 month, and 3 months after surgery
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Tijdsspanne: 12 hours, 24 hours, and 72 hours after surgery
12 hours, 24 hours, and 72 hours after surgery
Postoperative Analgesic Consumption
Tijdsspanne: During the first 3 days after surgery
During the first 3 days after surgery
Patient Satisfaction With Postoperative Swelling
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 juni 2026

Primaire voltooiing (Geschat)

29 september 2027

Studie voltooiing (Geschat)

30 september 2027

Studieregistratiedata

Eerst ingediend

12 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2026

Eerst geplaatst (Werkelijk)

20 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

17 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26412-ĐHYD

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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