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

Official 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

Overview

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.

Detailed description

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

Interventions

• Procedure Free gingival graft simultaneous with delayed implant placement
  XCM grafts (of bovine origin)
• Procedure Xenogeneic collagen matrix simultaneous with delayed implant placement
  A FGG will be harvested from the palate between first premolar and first molar

Primary outcome measures

• Keratinized tissue width [Time frame: One year]
• graft shrinkage [Time frame: One year]
• marginal bone loss [Time frame: One year]

Eligibility criteria

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),

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• MTI University — Cairo

Identifiers

NCT: NCT07080177 · MTI

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗