Healing After Augmentation of Alveolar Ridge Using Collagen Membrane

NCT ID: NCT06885983

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2029-11-01

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.

Detailed Description

The physiological process of bone tissue resorption after tooth extraction results in significant by changing the initial dimension of the alveolar ridge, due to horizontal and vertical resorption of bone tissue.this process is monitored and by a significant reduction in the volume of soft tissue and the width of the keratinized gingiva.Successful implant therapy is considered when the initial stability is achived of the embedded implant, which largely depends on the width alveolar ridge, at the place of its installation. However, despite achieving the initial stability, inadequate width of the alveolar ridge, and what according to the surgical protocol is a minimum of 1.5 mm. it is the cause of later complications due to present bone resorption processes and peri-implant soft tissue reduction. 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 trials have shown high degree of success of the regenerative therapy of the thinned buccal bone lamella, its deficiencies, as well as occurrences of dehiscence and fenestration, the treatment of which is carried out simultaneously with by inserting an implant. Moreover, simultaneous regenerative therapy of the mentioned bone defects with the installation of implants reduces the risk of buccal bony lamella and soft tissue collapse. Recent review paper and meta-analysis showed complete bony healing of fenestrations and dehiscence regardless of whether a bone substitute with or without collagen is used membrane, which is not the case if the operative region is covered only by mucoperiosteal flap, without regenerative therapy.

The primary goal of this research would be to determine the success of regenerative therapy bone and soft tissue from the buccal side.

Conditions

Bone Healing; Augmentation; Augmentation, Alveolar Ridge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Implant placement with augmentation

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.

Group Type: EXPERIMENTAL

implant placement

Intervention Type: PROCEDURE

Late implant placement without regenerative therapy

Guided bone regeneration

Intervention Type: PROCEDURE

Application of collagen membrane after implant placement.

Implant placement without augmentation

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.

Group Type: ACTIVE_COMPARATOR

implant placement

Intervention Type: PROCEDURE

Late implant placement without regenerative therapy

Interventions

implant placement

Late implant placement without regenerative therapy

Intervention Type: PROCEDURE

Guided bone regeneration

Application of collagen membrane after implant placement.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Bozidar Brkovic, DDS, MSc, PhD, Professor

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Sental Medicine

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

36/39/24

Identifier Type: -

Identifier Source: org_study_id