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

NCT07080177 | Not Yet Recruiting DMC

• 1 other identifier: MTI
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Keratinized tissue width

  mm

  One year

• graft shrinkage

  precentage

  One year

• marginal bone loss

  mm

  One year

Study Arms (2)

Xenogeneic collagen matrix simultaneous with delayed implant placement

EXPERIMENTAL

Tissue punch technique implants will be placed. XCM grafts (of bovine origin) will be trimmed to the required dimensions and will be fixed to the periosteum and sutured to the buccal peri-implant mucosa

Procedure: Xenogeneic collagen matrix simultaneous with delayed implant placement

Free gingival graft simultaneous with delayed implant placement

ACTIVE COMPARATOR

Tissue punch technique implants will be placed. A FGG will be harvested from the palate then the outlined graft will be placed and sutured to the recipient bed of the buccal peri-implant mucosa

Procedure: Free gingival graft simultaneous with delayed implant placement

Interventions

Free gingival graft simultaneous with delayed implant placement PROCEDURE

XCM grafts (of bovine origin)

Free gingival graft simultaneous with delayed implant placement

Xenogeneic collagen matrix simultaneous with delayed implant placement PROCEDURE

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

Xenogeneic collagen matrix simultaneous with delayed implant placement

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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),

Sponsors & Collaborators

• Cairo University: lead
• MTI University: collaborator

Study Sites (1)

MTI University

Cairo, Egypt

Location

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Parryhan M Abdelsamie, PhD

  MTI University

  PRINCIPAL INVESTIGATOR

• Maged M Seleet, PhD

  MTI University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parryhan M Abdelsamie, PhD

CONTACT

01003082353; Parryhan.abdelsamie@dentistry.cu.edu.eg

Maged M Seleet, PhD

CONTACT

01000367625

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of periodontology

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)