Healing After Augmentation of Alveolar Ridge Using Collagen Membrane

NCT06885983 | Enrolling By Invitation

• 1 other identifier: 36/39/24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

One of the prerequisites for successful prosthetic implant therapy of patients is achieving the initial stability of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. Regenerative therapy of the horizontal dimension of the alveolar ridge simultaneously with the installation of implants is carried out using biocompatible materials; a basket of thin ones substitutes and collagen membranes. Clinical application of the collagen matrix to date has shown successful regeneration soft tissue in corrective surgery of the oral mucosa, by increasing the volume of the gingiva, approximately as effective as the application of a connective tissue graft from the palate. In the current literature, there is no data on the cellular effects of the regeneration of soft, a especially bone tissue, after the application of a membrane with cross-linked collagen type I, u regenerative therapy of fenestrations, dehiscence and buccal contour augmentations bone lamellae, simultaneously with implant placement. Also, tissue monitoring mechanisms of regeneration of soft and bone tissue, has not been shown in the literature so far controlled and systematized results using the Primescan digital program scans and software analysis of soft tissue regeneration parameters, as well as their own correlations with CBCT and clinical analysis.

Conditions

Bone Healing; Augmentation; Augmentation, Alveolar Ridge

Keywords

Implantation; Augmenatation; CROSS-LINKED TYPE I COLLAGEN MEMBRANE

Outcome Measures

Primary Outcomes (1)

• Achived volume of the bone after implant placement and augmentation

  Assessment and comparative analysis quantity of newly formed bone and soft tissue using CBCT and digital, software analysis

  4 years

Study Arms (2)

Implant placement with augmentation

EXPERIMENTAL

Patients who are indicated for implant rehabilitation. Guided tissue regeneration employs augmentation with cross-linked type I collagen membrane to create different gingiva phenotype. The material will be placed after implantation using the following standard surgical protocols. Collagen membrane will serve as a barrier for epithelial cells and thereby promote bone healing.

Procedure: implant placement; Procedure: Guided bone regeneration

Implant placement without augmentation

ACTIVE COMPARATOR

Patient that needs implant placement in order for functional and aesthetic rehabilitation. Surgical procedures done in this group follow standard surgical protocols for implant placement without regenerative therapy.

Procedure: implant placement

Interventions

implant placement PROCEDURE

Late implant placement without regenerative therapy

Implant placement with augmentation; Implant placement without augmentation

Guided bone regeneration PROCEDURE

Application of collagen membrane after implant placement.

Implant placement with augmentation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I classification of health status,
• Non-smokers or consumption of up to 10 cigarettes per day,
• No signs of gingival inflammation,
• Late installation of implants,
• The possibility of achieving the primary stability of the implant,
• The dimension of the residual alveolar ridge for implant placement ≥5 mm wide, height ≥12 mm,
• Diagnosed fenestration, dehiscence of buccal bony lamella ≤3 mm in size and/or thickness of buccal bone lamella ≤1.5 mm,
• Plaque index (PI) and gingival bleeding on provocation (KNP) \<15% and probing depth (DS) \<3 mm,
• Preserved cemento-enamel border (CGG) without the presence of non-carious cervical lesions (NCL), or the presence of a defect in the root area up to 1mm deep with preserved CGG,
• Preserved interjaw relationships.

You may not qualify if:

• Systemic acute administration of drugs up to 7 days before surgical intervention,
• Systemic chronic administration of steroids or non-steroidal anti-inflammatory drugs,
• History of oral surgical interventions in the last 4 months,
• Poor oral hygiene,
• Demonstrated hypersensitivity to collagen,
• Pregnancy and breastfeeding,
• Patient withdrawal from the research protocol in any evaluation period,
• Patients who underwent standard augmentation of bone tissue with a substitute for bone and membrane, after implant installation,
• Participation in clinical research in the last 6 months

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

School of Sental Medicine

Belgrade, 011, Serbia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: March 7, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

SE (1)