Lateral Ridge Augmentation Around Implants

NCT04197128 | Unknown

• 1 other identifier: 02_D012_101329
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The rehabilitation of dentoalveolar defects and tooth loss has seen remarkable advancements over time. Extraction of tooth leads to reduction in physiologic dimension of bone and it is imperative to evaluate the site before implant placement. To overcome the loss of volume and to avoid complications, procedures to restore the resorbed alveolar bones prior to or during implant placement are usually performed. Lateral bone augmentation procedures with guided bone regeneration (GBR) are well documented in the literature with predictable results. It generally involves bone substitute xenograft and bioresorbable membrane combined with implant placement in single stage procedure or separately in two- stage procedure. As the search for better and improved materials continues, a porcine derived ribose cross-linked volumising collagen matrix (VCMX) based on GLYMATRIX® technology has been introduced which showed benefits over the conventional membranes in terms of simplified procedure, degradation, membrane exposure and healing. The collagen scaffold has been reportedly used as a core material for guided bone regeneration, when there is sufficient bone to place an implant but a horizontal defect is present in the crestal ridge. As part of augmentation VCMX is designed to expand and ossify during healing. The advantage of the material is that when placed in one or two layers, it may eliminate the use of bone substitute or connective tissue graft thus simplifying the augmentation procedure. In addition, adding a bone substitute is a valid option based on indication. In the quest of better material and simplified procedures, few authors have performed case studies based on application of VCMX for guided bone regeneration around dental implants and has shown promising results. However, there are no controlled clinical trials on application of VCMX for lateral ridge augmentation. Thus, the present study aims to assess the efficiency of VCMX compared to resorbable collagen membrane (RCM) and bone graft (BG) for lateral ridge augmentation around implants through a well designed, controlled clinical trial.

Conditions

Alveolar Bone Resorption

Keywords

Lateral augmentation; Ribose cross-linked collagen; Dental Implant

Outcome Measures

Primary Outcomes (2)

• Ridge width

  Ridge width would be measured pre-operatively and post-operatively using Cone beam computed tomography.

  6 months

• Gingival thickness

  Clinical and radiographic assessment would be performed

  6 months

Secondary Outcomes (4)

• Patient- reported outcome 1

  6 months

• Patient reported outcome 2

  6 months

• Safety evaluation 1

  6 months

• Safety evaluation 2

  6 months

Study Arms (2)

Resorbable collagen membrane and bone graft

ACTIVE COMPARATOR

Subjects will receive bovine derived bone graft and resorbable collagen membrane for augmentation.

Device: Resorbable Collagen membrane with bone graft for augmentation

Ribose cross-linked collagen matrix

EXPERIMENTAL

Subjects will receive ribose cross linked collagen matrix for augmentation

Device: Ribose cross linked collagen matrix for augmentation

Interventions

Resorbable Collagen membrane with bone graft for augmentation DEVICE

Local anaesthesia Lignocaine and Adrenaline 1:80000 Injection (Lignox® 2% A, Indoco remedies Ltd, Mumbai) will be administered and midcrestal incison will be made and full thickness flap would be raised buccally. To obtain tension free adaptation of flap margins, the buccal flap advancement will be done using periosteal releasing incision. Implant osteotomies will be performed with sequential drilling and with standardised drills. All the subjects will receive the same implant system. (Norris medical ltd. Hatasia street, Nesher, Israel) For augmentation of deficient ridge, bovine bone graft will be place with overlying resorbable collagen membrane. Stabilisation would be achieved with internal resorbable horizontal mattress suture. The tension free flap margins will be adapted around the healing abutment with simple interrupted Vicryl 4.0, 3/8, reverse cutting resorbable sutures (Ethicon, Hamburg, Germany)

Also known as: Cerabone®, Ossix Plus®

Resorbable collagen membrane and bone graft

Ribose cross linked collagen matrix for augmentation DEVICE

Local anaesthesia Lignocaine and Adrenaline 1:80000 Injection (Lignox® 2% A, Indoco remedies Ltd, Mumbai) will be administered and midcrestal incison will be made and full thickness flap would be raised buccally. To obtain tension free adaptation of flap margins, the buccal flap advancement will be done using periosteal releasing incision. Implant osteotomies will be performed with sequential drilling and with standardised drills. All the subjects will receive the same implant system. (Norris medical ltd. Hatasia street, Nesher, Israel) For augmentation of deficient ridge, ribose cross linked collagen matrix will be cut and adapted to the buccal wall and ridge around the buccal aspect of healing abutment. Stabilisation would be achieved with internal resorbable horizontal mattress suture. The tension free flap margins will be adapted around the healing abutment with simple interrupted 4.0, 3/8, reverse cutting resorbable sutures (Ethicon, Hamburg, Germany).

Also known as: Ossix Volumax®

Ribose cross-linked collagen matrix

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cooperative patients willing to participate in the study belonging to 20-50 years of age group
• Patients indicated for implant placement
• Based on SAC classification (Straight forward, Advanced, Complex), if the bone defect has at least two walls intact and implant placement is possible within the confines of ridge.10 In the present study, subjects belonging to Advanced category i.e., where simultaneous guided bone regeneration and implant placement is possible it would be considered.
• Full mouth plaque score (FMPS) \< 20 %, Full mouth bleeding score (FMBS) \< 20 %.11
• Ability to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations.
• Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form.

You may not qualify if:

• Smokers
• Probing depth \>4 mm
• General contraindications for dental and/or surgical treatment
• History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 yrs
• Pregnancy or breast feeding
• Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
• History of any allergic diseases -

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya College of Dental Sciences and Hospital

Bengaluru, Karnataka, 562157, India

RECRUITING

Related Publications (3)

• Friedmann A, Gissel K, Soudan M, Kleber BM, Pitaru S, Dietrich T. Randomized controlled trial on lateral augmentation using two collagen membranes: morphometric results on mineralized tissue compound. J Clin Periodontol. 2011 Jul;38(7):677-85. doi: 10.1111/j.1600-051X.2011.01738.x. Epub 2011 May 10.

  PMID: 21557757 BACKGROUND

• Zubery Y, Nir E, Goldlust A. Ossification of a collagen membrane cross-linked by sugar: a human case series. J Periodontol. 2008 Jun;79(6):1101-7. doi: 10.1902/jop.2008.070421.

  PMID: 18533790 BACKGROUND

• Smidt A, Gutmacher Z, Sharon E. A nouveau collagen scaffold to simplify lateral augmentation of deficient ridges between natural teeth. Quintessence Int. 2019;50(7):576-582. doi: 10.3290/j.qi.a42652.

  PMID: 31161157 BACKGROUND

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Prabhuji MLV, MDS

  Krishnadevaraya College of Dental Sciences

  STUDY DIRECTOR

• Karthikeyan Bangalore Varadhan, MDS

  Krishnadevaraya College of Dental Sciences

  STUDY DIRECTOR

Central Study Contacts

Ashwin P S, MDS

CONTACT

8050364485; psbhatashwin@gmail.com

Prabhuji MLV, MDS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of the Department

Model Details: The subjects are randomly divided into 2 groups i.e., Control and Test group each consisting of equal number of participants who are age and sex matched.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: August 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: January 20, 2021
• Last Updated: January 3, 2020

Record last verified: 2019-12

Locations

IN (1)