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Comparison of Freeze-Dried Amniotic and Collagen Membranes for Soft Tissue Healing After Grafted Implant Surgery (FDAM-CM)

10. června 2026 aktualizováno: RAJAS DENTAL COLLEGE AND HOSPITAL

Comparison of Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in Soft Tissue Healing After Stage 1 Implant Surgery With Particulate Grafting: An In Vivo Study

The goal of this clinical trial is to learn whether Freeze-Dried Amniotic Membrane (FD-AM) or Collagen Membrane (CM) provides better soft tissue healing after Stage I dental implant surgery with particulate bone grafting in adults requiring implant treatment in bilateral posterior maxillary edentulous sites. It will also evaluate postoperative pain associated with the two membrane types.

The main questions it aims to answer are:

Does FD-AM result in improved early soft tissue healing compared with CM as assessed by the Early Healing Score (EHS)? Does FD-AM reduce postoperative pain compared with CM as assessed by the Visual Analogue Scale (VAS)?

Researchers will compare FD-AM and CM placed over grafted implant sites to determine whether one membrane provides superior healing outcomes and patient comfort.

Participants will:

Undergo Stage I implant surgery with particulate bone grafting. Receive FD-AM at one implant site and CM at the contralateral implant site according to the study randomization protocol.

Attend follow-up visits for assessment of soft tissue healing and postoperative pain.

Complete questionnaires related to pain and healing outcomes during the postoperative period.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This prospective interventional in vivo study was conducted in the Department of Advanced Dental Sciences, Rajas Dental College and Hospital, to compare the effectiveness of Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) in promoting soft tissue healing following Stage I implant surgery with particulate bone grafting.

A total of 10 partially edentulous patients with bilateral posterior maxillary edentulous sites meeting the predefined inclusion and exclusion criteria were recruited. The study employed a split-mouth design in which each patient contributed two implant sites, allowing direct within-patient comparison of the two membrane types. One site received FD-AM and the contralateral site received CM according to a randomization protocol based on a simple coin toss performed by an independent individual not involved in surgery or outcome assessment.

The study included patients aged 25-55 years presenting with bilateral posterior maxillary edentulous areas, immediate implant placement requirements following extraction, or delayed implant placement in ridge defects requiring grafting. Patients with smoking history, pregnancy, systemic diseases affecting bone metabolism, active periodontal disease, infectious diseases, vitamin D deficiency, or known allergies to study materials were excluded.

All surgical procedures were performed under aseptic conditions using standard implant surgical protocols. Following implant placement, xenogeneic demineralized bone matrix graft material (Osseograft) was placed around the implant site as required. Platelet-Rich Fibrin (PRF) was prepared from autologous venous blood and used to enhance the regenerative environment. Barrier membranes were adapted over the grafted sites to facilitate guided bone regeneration and were followed by primary wound closure using interrupted sutures.

The primary outcome measure was soft tissue healing assessed using the Early Healing Score (EHS) by a blinded examiner. Secondary outcome assessment included postoperative pain evaluation using a Visual Analogue Scale (VAS) and structured questionnaires administered during follow-up visits.

The study aimed to determine whether FD-AM provides comparable or superior soft tissue healing compared with conventional collagen membranes. The results demonstrated favorable healing responses with both membrane types, characterized by adequate hemostasis, absence of significant inflammatory signs, and satisfactory epithelialization during the early healing period. The findings suggest that both FD-AM and CM are effective barrier membranes for supporting early soft tissue healing and guided bone regeneration around dental implants.

Typ studie

Intervenční

Zápis (Aktuální)

10

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Indie
    • Tamil Nadu
      • Kavalkinaru, Tamil Nadu, Indie, 627105
        • Rajas Dental College and Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Adults aged 25-55 years.
  • Male and female participants.
  • Bilateral posterior maxillary edentulous area in the premolar region (Bedrossian Zone 2 classification).
  • Patients with teeth requiring extraction and eligible for immediate implant placement in the bilateral posterior maxillary region.
  • Patients with ridge defects classified as Siebert Class II or Class III and eligible for delayed implant placement in the bilateral posterior maxillary region.

Exclusion Criteria:

  • Current smokers.
  • History of systemic diseases affecting bone turnover, including hyperthyroidism (T4 outside 5.0-12.0 μg/dL or T3 outside 80-220 ng/dL), Type I diabetes mellitus (HbA1c > 6%), Cushing's disease, or hyperlipidemia.
  • Pregnant women.
  • Lactating mothers.
  • Presence of periodontal disease.
  • Known allergy to study materials or medications.
  • Blood-borne infectious diseases, including HIV or HBsAg positivity.
  • Vitamin D level < 30 ng/mL.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Freeze-Dried Amniotic Membrane (FD-AM) Group
Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Freeze-Dried Amniotic Membrane (FD-AM) was adapted and placed over the grafted area to facilitate guided bone regeneration and enhance soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS).
Přístroj: Freeze-Dried Amniotic Membrane (FD-AM)
Freeze-Dried Amniotic Membrane (FD-AM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and promoting soft tissue healing during the postoperative period.
Ostatní jména:
  • Amniotic Membrane FD-AM
Experimentální: Collagen Membrane (CM) Group
Participants underwent Stage I implant surgery with particulate bone grafting at the implant site. Following graft placement, a Collagen Membrane (CM) was adapted and placed over the grafted area to facilitate guided bone regeneration and support soft tissue healing. Postoperative healing was evaluated using the Early Healing Score (EHS) and Visual Analogue Scale (VAS).
Přístroj: Collagen Membrane (CM)
Collagen Membrane (CM) was placed over the particulate bone grafted implant site following Stage I implant surgery. The membrane was trimmed and adapted to cover the grafted area, serving as a barrier membrane for guided bone regeneration and supporting soft tissue healing during the postoperative period.
Ostatní jména:
  • Collagen Barrier Membrane CM

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Early Healing Score
Časové okno: 1 week and 2 weeks

Assessment and comparison of soft tissue healing around bone-grafted implant sites covered with Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) following Stage I implant surgery using the Early Healing Score (EHS). The EHS evaluates wound healing based on three clinical parameters:

Clinical Signs of Re-epithelialization (CSR): 0 = visible distance between incision margins; 3 = incision margins in contact; 6 = merged incision margins.

Clinical Signs of Haemostasis (CSH): 0 = bleeding at incision margins; 1 = presence of fibrin ; 2 = absence of fibrin. Clinical Signs of Inflammation (CSI): 0 = redness involving >50% of incision length and/or pronounced swelling; 1 = redness involving <50% of incision length; 2 = absence of redness along incision length.

The EHS is calculated as the sum of CSR, CSH, and CSI scores , where 0 represents the poorest healing and 10 represents ideal wound healing. Higher scores indicate better soft tissue healing outcomes.
1 week and 2 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Postoperative Pain Assessment Using Visual Analogue Scale (VAS)
Časové okno: 1 week and 2 weeks
Assessment and comparison of postoperative pain at bone-grafted implant sites covered with Freeze-Dried Amniotic Membrane (FD-AM) and Collagen Membrane (CM) using the Visual Analog Scale (VAS). Participants rate pain intensity on a scale from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain severity and a worse outcome.
1 week and 2 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

RAJAS DENTAL COLLEGE AND HOSPITAL

Vyšetřovatelé

  • Studijní židle: Alex M Muruppel, MDS, Rajas Dental College and Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

19. června 2025

Primární dokončení (Aktuální)

27. ledna 2026

Dokončení studie (Aktuální)

18. února 2026

Termíny zápisu do studia

První předloženo

6. června 2026

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

15. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • RDCH/PRL/IEC/D-0138/2024 (Jiný identifikátor: Rajas Dental College & Hospital Institutional Ethics Committee)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual Participant Data (IPD) will not be shared because the study was conducted as part of an academic postgraduate research project, and no formal data-sharing plan was established. Participant confidentiality and privacy will be maintained in accordance with institutional ethics requirements.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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