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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07080177
Enrollment
24
Registered
2025-07-23
Start date
2025-09-22
Completion date
2026-12-31
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Missing Teeth

Keywords

xenogeneic collagen membrane, free gingival graft, xenogeneic collagen matrices, simultaneous implant placement

Brief summary

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

PROCEDUREFree gingival graft simultaneous with delayed implant placement

XCM grafts (of bovine origin)

PROCEDUREXenogeneic collagen matrix simultaneous with delayed implant placement

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

Sponsors

MTI University
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Adults above the age of 18 years. 2. Presence of 2mm or less of keratinized tissue width 3. Sufficient alveolar ridge width minimum of 6 mm 4. Patients with good oral hygiene as evidenced by plaque index (PI)\<1 and showing cooperation or compliance with treatment.

Exclusion criteria

1. Patients diagnosed with periodontal diseases (Caton et al., 2018). 2. Acute active infection at implant sites 3. Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous bisphosphonates for treatment of osteoporosis and radiotherapy 4. Patients with parafunctional habits. 5. Smokers (≥10 cigarettes per day),

Design outcomes

Primary

MeasureTime frameDescription
Keratinized tissue widthOne yearmm
graft shrinkageOne yearprecentage
marginal bone lossOne yearmm

Countries

Egypt

Contacts

Primary ContactParryhan M Abdelsamie, PhD
Parryhan.abdelsamie@dentistry.cu.edu.eg01003082353
Backup ContactMaged M Seleet, PhD
01000367625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026