Clinical trial NCT06808243: Modified Periosteal Tissue Graft vs Collagen Matrix for Soft Tissue Augmentation Around Implants: A Comparative Study
Official title: Modified Vascularized Interpostional Periosteal Connective Tissue Graft Versus Xenogeneic Collagen Matrix for Soft Tissue Augmentation Around Implant in Esthetic Zone (Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental
Implant
Keywords: implant
connective tissue graft
xenogenic membrane
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to evaluate the effectiveness of the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (mVIP-CTG) compared to Xenogeneic Collagen Matrix (XCM) around immediate implant in esthetic zone . This study will assess outcomes such as keratinized tissue thickness, keratinized tissue width, pink esthetic score and radiographic buccal cortex thickness over a defined follow-up period. By comparing mVIP-CTG to XCM, the study seeks to determine which method provides superior clinical and aesthetic results for best soft tissue augmentation

Detailed description: This study investigates two surgical techniques for managing peri-implant soft tissue deficiencies: the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (VIP-CTG) and the Xenogeneic Collagen Matrix (XCM). Peri-implant soft tissue deficiencies, characterized by inadequate tissue volume or recession around dental implants, can lead to complications such as implant exposure, sensitivity, and aesthetic concerns. Conventional treatment methods aim to enhance soft tissue volume and improve the aesthetic and functional outcomes of implants.

The mVIP-CTG approach utilizes autogenous pedicle grafts to improve tissue thickness and width, potentially enhancing soft tissue integration and thickness around immediate implants. In contrast, XCM is a xenogenic membrane offering a minimally invasive alternative substitute for soft tissue regeneration.

The study design includes randomized assignment of participants to either the mVIP-CTG group or XCM group, with standardized surgical and follow-up protocols. Primary and secondary outcomes will include peri-implant soft tissue thickness, keratinized tissue width, pink esthetic score, and radiographic buccaal cortex thickness. Statistical analysis will evaluate the comparative effectiveness of both techniques in promoting peri-implant soft tissue regeneration and aesthetic recovery.

Eligibility criteria: Inclusion Criteria: -

* systemically healthy
* teeth indicated for extraction due to trauma or root fracture
* periodontally healthy
* Good oral health
* Selected patients of both sexes are 20-40 years old.

Exclusion Criteria:

* parafunctional habits
* smoking, alcoholism
* pregnancy
* lactation
* untreated periodontal diseases

Primary outcomes:
measure: keratinized tissue thickness
timeFrame: baseline, 3 months, 6 months
measure: keratinized tissue width
timeFrame: baseline, 3 months and 6 months
measure: buccal cortex thickness
timeFrame: baseline and 6 months
Secondary outcomes:
measure: pink esthetic score
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Hospital of faculty of dentistry, Minia university
Study officials:
affiliation: Minia University
name: Heba Ah Abdel-maged, MSc
role: PRINCIPAL_INVESTIGATOR
References: