Alveolar Bone ResorptionNCT04197128
Lateral Ridge Augmentation Around Implants
A study testing Resorbable Collagen membrane with bone graft for augmentation and Ribose cross linked collagen matrix for augmentation in people with Alveolar Bone Resorption, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Resorbable Collagen membrane with bone graft for augmentation and Ribose cross linked collagen matrix for augmentation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2019to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Prabhuji MLV, MDS contact
India1 site, 1 recruiting
- Recruiting
Krishnadevaraya College of Dental Sciences and Hospital
Bengaluru, Karnataka, 562157
Ashwin P S, MDS, 8050364485, psbhatashwin@gmail.com
About this study
Official title: Comparative Evaluation of Novel Ribose Cross Linked Volumising Collagen Matrix v/s Ribose Cross Linked Resorbable Collagen Membrane and Bone Graft for Lateral Ridge Augmentation Around Implants: A Randomised Controlled Clinical Trial
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.
Read the detailed description
Source of data Patient visiting the Outpatient Section of the Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital for replacement of lost teeth will be screened and randomly recruited for the study as per inclusion and exclusion criteria. The eligible subjects will be informed of the nature and benefits of the participation of the study and a written signed consent will be obtained.
Method of collection of data Sample Size The study would be a prospective, randomized controlled clinical trial. A sample size of 28 subjects with equal number of males and females who are eligible as per the inclusion criteria, belonging to 20 - 50 years of age group would be considered for the study. Sample size is calculated using online software (OpenEpi) Open Source Epidemiologic Statistics for Public Health, Version 3.01. Estimation is done considering a similar previous study to acquire 80% power and 5% type 1 error in power calculation.
- Conditions
- Alveolar Bone Resorption
- Being tested
- Resorbable Collagen membrane with bone graft for augmentation, Ribose cross linked collagen matrix for augmentation
- Keywords
- Lateral augmentation, Ribose cross-linked collagen, Dental Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resorbable Collagen membrane with bone graft for augmentationDevice
Also called Cerabone®, Ossix Plus®
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)
Ribose cross linked collagen matrix for augmentationDevice
Also called Ossix Volumax®
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).
| Study group | Role | What they receive |
|---|---|---|
| Resorbable collagen membrane and bone graft | Active comparator | Subjects will receive bovine derived bone graft and resorbable collagen membrane for augmentation. Receives: 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 Receives: Device: Ribose cross linked collagen matrix for augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge width
Ridge width would be measured pre-operatively and post-operatively using Cone beam computed tomography.
Measured: 6 months
Gingival thickness
Clinical and radiographic assessment would be performed
Measured: 6 months
Secondary outcomes (4)
Patient- reported outcome 1
Post operative pain and discomfort would be measured using Visual analogue scale
Measured: 6 months
Patient reported outcome 2
Number of analgesics consumed would be assessed during post- operative period
Measured: 6 months
Safety evaluation 1
Number of subjects with adverse healing
Measured: 6 months
Safety evaluation 2
Number of subjects who had membrane exposure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Aug 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion20 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
- Investigators
- Prabhuji MLV, MDS, Study director, Krishnadevaraya College of Dental SciencesKarthikeyan Bangalore Varadhan, MDS, Study director, Krishnadevaraya College of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197128
- Sponsor's protocol ID
- 02_D012_101329
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21557757Zubery 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.
PubMed 18533790Smidt 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.
PubMed 31161157
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Novel Ribose Cross Linked Volumising Collagen Matrix v/s Ribose Cross Linked Resorbable Collagen Membrane and Bone Graft for Lateral Ridge Augmentation Around Implants: A Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04197128
- Acronym / sponsor ID
- 02_D012_101329
- Conditions
- Alveolar Bone Resorption
- Keywords
- Lateral augmentation, Ribose cross-linked collagen, Dental Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 20 Jan 2021 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Source of data Patient visiting the Outpatient Section of the Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital for replacement of lost teeth will be screened and randomly recruited for the study as per inclusion and exclusion criteria. The eligible subjects will be informed of the nature and benefits of the participation of the study and a written signed consent will be obtained.
Method of collection of data Sample Size The study would be a prospective, randomized controlled clinical trial. A sample size of 28 subjects with equal number of males and females who are eligible as per the inclusion criteria, belonging to 20 - 50 years of age group would be considered for the study. Sample size is calculated using online software (OpenEpi) Open Source Epidemiologic Statistics for Public Health, Version 3.01. Estimation is done considering a similar previous study to acquire 80% power and 5% type 1 error in power calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resorbable collagen membrane and bone graft | Active comparator | Device: Resorbable Collagen membrane with bone graft for augmentationSubjects will receive bovine derived bone graft and resorbable collagen membrane for augmentation. |
| Ribose cross-linked collagen matrix | Experimental | Device: Ribose cross linked collagen matrix for augmentationSubjects will receive ribose cross linked collagen matrix for augmentation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resorbable Collagen membrane with bone graft for augmentationAlso: Cerabone®, Ossix Plus®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) | Device | Resorbable collagen membrane and bone graft |
| Ribose cross linked collagen matrix for augmentationAlso: Ossix Volumax®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). | Device | Ribose cross-linked collagen matrix |
Primary outcome
Ridge width
Time frame: 6 months
Ridge width would be measured pre-operatively and post-operatively using Cone beam computed tomography.
Gingival thickness
Time frame: 6 months
Clinical and radiographic assessment would be performed
4 secondary outcomes
Patient- reported outcome 1
Time frame: 6 months
Patient reported outcome 2
Time frame: 6 months
Safety evaluation 1
Time frame: 6 months
Safety evaluation 2
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Background: PubMed 21557757Friedmann 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.
- Background: PubMed 18533790Zubery 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.
- Background: PubMed 31161157Smidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prabhuji MLV, MDS contact
Prabhuji MLV, MDS study director
Krishnadevaraya College of Dental Sciences
Karthikeyan Bangalore Varadhan, MDS study director
Krishnadevaraya College of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resorbable Collagen membrane with bone graft for augmentation and Ribose cross linked collagen matrix for augmentation in people with Alveolar Bone Resorption, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashwin P S, MDS (8050364485 ext. 91, psbhatashwin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ridge width (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04197128, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.