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NCT Number: NCT07080177

Assessment of Hard and Soft Tissue Changes Following XCM Versus FGG Simultaneous With Delayed Dental Implant Placement

Teeth loss are usually associated with alterations of extraction sockets result in obviously absorbed alveolar ridges and are often accompanied with soft tissue atrophy such as narrow keratinized tissue and a shallow vestibule.

Lack of peri-implant keratinized tissue is a potential risk to peri-implant diseases. Although the role of width of KM in maintaining peri-implant health is a controversial topic, the majority of high-level evidence has suggested that a minimum KM width (KMW) of 2 mm around the dental implants is critical to maintain peri-implant health and the long-term survival of dental implants.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MTI University

Cairo, Egypt

About this study

This study will be carried out on patients attending outpatient clinic of Oral maxillofacial surgery and Periodontology Departments, Faculty of Dentistry. Modern University for Technology and Information, Cairo, Egypt.

P: Healthy patients with posterior missing teeth with deficient keratinized tissue to receive delayed dental implant placement I: Xenogeneic collagen membrane (XCM) simultaneous with delayed implant placement C: Free gingival graft (FGG) simultaneous with delayed implant placement O: Keratinized tissue width (KMW), graft shrinkage (GS), marginal bone loss (MBL) T- One year S- Randomized controlled clinical trial.

Eligible patients will be divided into equal proportions between control group and test group.

The control group "Group 1" will receive FGG simultaneous with implant placement The test group "Group 2" will receive XCM simultaneous with implant placement

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults above the age of 18 years.
  • Presence of 2mm or less of keratinized tissue width
  • Sufficient alveolar ridge width minimum of 6 mm
  • Patients with good oral hygiene as evidenced by plaque index (PI)<1 and showing cooperation or compliance with treatment.

Exclusion criteria

  • Patients diagnosed with periodontal diseases (Caton et al., 2018).
  • Acute active infection at implant sites
  • Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous bisphosphonates for treatment of osteoporosis and radiotherapy
  • Patients with parafunctional habits.
  • Smokers (≥10 cigarettes per day),

Treatment and study plan

Free gingival graft simultaneous with delayed implant placement

Procedure

XCM grafts (of bovine origin)

Xenogeneic collagen matrix simultaneous with delayed implant placement

Procedure

A FGG will be harvested from the palate between first premolar and first molar

Primary outcomes

  1. Keratinized tissue width

    Time frame: One year

    mm

  2. graft shrinkage

    Time frame: One year

    precentage

  3. marginal bone loss

    Time frame: One year

    mm

Study contacts

Contact information is provided by the study sponsor or research team.

Maged M Seleet, PhD

CONTACT

01000367625

Parryhan M Abdelsamie, PhD

CONTACT

[email protected]

01003082353

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • MTI University

Registry information

Official study title

Assessment of Hard and Soft Tissue Changes Following Xenogeneic Collagen Membrane Versus Free Gingival Graft Simultaneous With Delayed Dental Implant Placement: Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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