Immediate ImplantNCT06552065
Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants
A study testing collagen with silk fibroin membrane and cross linked collagen membrane in people with Immediate Implant, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant
- What is being tested?
- collagen with silk fibroin membrane and cross linked collagen membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2024to Aug 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patients in the age group of 18 to 55years.
- Patients undergoing immediate implant placement with gingival thickness ≤ 1mm
- Stage II /Stage III and Grade B Periodontitis patients.
- Radiographic assessment using Radiovisiography (RVG) with grid.
Who cannot join
- Patients having allergies with collagen and silk products.
- Medical conditions contraindicating surgical interventions.
- Known smokers and alcoholic.
- Acute infections at the site of extraction. Ex Abscess.
- Patients who have undergone radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
India1 site
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
About this study
Official title: Comparative Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants -Randomized Controlled Trial.
Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.
Read the detailed description
Periodontal disease is an inflammatory and infectious disease affecting the tooth supporting structures leading to tooth loss when left untreated.The detrimental effect of periodontitis results in soft tissue and hard tissue loss. Bone defects has often resulted from tumor resection, congenital malformation, trauma, fractures, surgery, periodontitis or around implants in dentistry, as well as from diseases, such as osteoporosis or arthritis.These deficiencies have been overcome through various treatment modalities.It is a well-established fact that the cells from the periodontal ligament have the potential for regeneration of the tooth attachment apparatus. In addition, bone grafts and membranes have been used to regenerate the lost bone.
Among the membranes, autogenous connective tissue graft remains as gold standard. Collagen is biocompatible natural polymer that has a good function to promote new tissue formation. In the proposed study, immediate implants with compromised bone support, cross-linked bovine collagen membrane will be used. It is a naturally occurring protein, having excellent biocompatibility, and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments. Further, it is resistant to tension, controllable biodegradability, is non cytotoxic, low antigenicity, and excellent anti-inflammatory characteristics. It is naturally reabsorbed by microorganisms, easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted, leading to improved immunogenicity.
Bovine collagen is selected to enhance the biological function of silk fibroin, as composite membrane for enhancement of gingival thickness. Thus, considering all these characteristics, silk fibroin is incorporated into collagen membrane for evaluation .As there is no literature assessing this composite membrane, the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken.
- Conditions
- Immediate Implant
- Being tested
- collagen with silk fibroin membrane, cross linked collagen membrane
- Keywords
- Silk fibroin with collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collagen with silk fibroin membraneOther
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol .
The surgical wound closure will be coapted with mattress and single interrupted sutures
cross linked collagen membraneOther
A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| 10 will receive cross -linked collagen with silk fibroin membrane around immediate implant. | Experimental | Local anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen with silk fibroin membrane. Suture is done. Receives: Other: collagen with silk fibroin membrane; Other: cross linked collagen membrane |
| 10 will receive cross linked collagen membrane around immediate implant | Active comparator | Local anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen membrane. Suture is done. Receives: Other: collagen with silk fibroin membrane; Other: cross linked collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess wound healing, gingival thickness and keratinized tissue width
Gingival tissue thickness assessment will be done at the site of implant placement 1.5 mm below the gingival margin of adjacent tooth. Local anaesthesia will be administered before the procedure and an Endodontic K-file with silicone disc stop will be used to measure. The depth will be measured with UNC-15 probe.
Apico-coronal width of keratinized tissue is measured as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction determined using Schiller's Potassium Iodide Solution.
Measured: pre implant placement , 6 weeks , 12 weeks
Secondary outcomes (1)
Radiovisiography with grid
assess increase in bone volume
Measured: pre implant placement , 6 weeks , 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immediate ImplantStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552065
- Sponsor's protocol ID
- 02-D012-00050
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared with other researchers.
Publications
Pripatnanont P, Chankum C, Meesane J, Thonglam J. Physical and biological performances of a semi-resorbable barrier membrane based on silk fibroin-glycerol-fish collagen material for guided bone regeneration. J Biomater Appl. 2021 Nov;36(5):930-942. doi: 10.1177/08853282211025781. Epub 2021 Jun 21.
PubMed 34152233
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants -Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06552065
- Acronym / sponsor ID
- 02-D012-00050
- Conditions
- Immediate Implant
- Keywords
- Silk fibroin with collagen membrane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.
Detailed description
Periodontal disease is an inflammatory and infectious disease affecting the tooth supporting structures leading to tooth loss when left untreated.The detrimental effect of periodontitis results in soft tissue and hard tissue loss. Bone defects has often resulted from tumor resection, congenital malformation, trauma, fractures, surgery, periodontitis or around implants in dentistry, as well as from diseases, such as osteoporosis or arthritis.These deficiencies have been overcome through various treatment modalities.It is a well-established fact that the cells from the periodontal ligament have the potential for regeneration of the tooth attachment apparatus. In addition, bone grafts and membranes have been used to regenerate the lost bone.
Among the membranes, autogenous connective tissue graft remains as gold standard. Collagen is biocompatible natural polymer that has a good function to promote new tissue formation. In the proposed study, immediate implants with compromised bone support, cross-linked bovine collagen membrane will be used. It is a naturally occurring protein, having excellent biocompatibility, and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments. Further, it is resistant to tension, controllable biodegradability, is non cytotoxic, low antigenicity, and excellent anti-inflammatory characteristics. It is naturally reabsorbed by microorganisms, easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted, leading to improved immunogenicity.
Bovine collagen is selected to enhance the biological function of silk fibroin, as composite membrane for enhancement of gingival thickness. Thus, considering all these characteristics, silk fibroin is incorporated into collagen membrane for evaluation .As there is no literature assessing this composite membrane, the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 will receive cross -linked collagen with silk fibroin membrane around immediate implant. | Experimental | Other: collagen with silk fibroin membrane, Other: cross linked collagen membraneLocal anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen with silk fibroin membrane. Suture is done. |
| 10 will receive cross linked collagen membrane around immediate implant | Active comparator | Other: collagen with silk fibroin membrane, Other: cross linked collagen membraneLocal anesthesia is given. Atraumatic extraction is done. Osteotomy is done. Immediate implant is placed along with crosslinked collagen membrane. Suture is done. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically healthy patients in the age group of 18 to 55years.
- Patients undergoing immediate implant placement with gingival thickness ≤ 1mm
- Stage II /Stage III and Grade B Periodontitis patients.
- Radiographic assessment using Radiovisiography (RVG) with grid.
Key exclusion criteria (5 listed)
- Patients having allergies with collagen and silk products.
- Medical conditions contraindicating surgical interventions.
- Known smokers and alcoholic.
- Acute infections at the site of extraction. Ex Abscess.
- Patients who have undergone radiotherapy or chemotherapy.
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 |
|---|---|---|
| collagen with silk fibroin membraneA mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol. An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol . The surgical wound closure will be coapted with mattress and single interrupted sutures | Other | 10 will receive cross -linked collagen with silk fibroin membrane around immediate implant., 10 will receive cross linked collagen membrane around immediate implant |
| cross linked collagen membraneA mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol. | Other | 10 will receive cross -linked collagen with silk fibroin membrane around immediate implant., 10 will receive cross linked collagen membrane around immediate implant |
Primary outcome
To assess wound healing, gingival thickness and keratinized tissue width
Time frame: pre implant placement , 6 weeks , 12 weeks
Gingival tissue thickness assessment will be done at the site of implant placement 1.5 mm below the gingival margin of adjacent tooth. Local anaesthesia will be administered before the procedure and an Endodontic K-file with silicone disc stop will be used to measure. The depth will be measured with UNC-15 probe. Apico-coronal width of keratinized tissue is measured as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction determined using Schiller's Potassium Iodide Solution.
1 secondary outcome
Radiovisiography with grid
Time frame: pre implant placement , 6 weeks , 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 34152233Pripatnanont P, Chankum C, Meesane J, Thonglam J. Physical and biological performances of a semi-resorbable barrier membrane based on silk fibroin-glycerol-fish collagen material for guided bone regeneration. J Biomater Appl. 2021 Nov;36(5):930-942. doi: 10.1177/08853282211025781. Epub 2021 Jun 21.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared with other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collagen with silk fibroin membrane and cross linked collagen membrane in people with Immediate Implant, 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 4 inclusion and 5 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 13 Aug 2024. 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 jyoti naik, bds (7337673040, jyotitnaik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess wound healing, gingival thickness and keratinized tissue width (time frame: pre implant placement , 6 weeks , 12 weeks). 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 NCT06552065, which also lists 1 linked publication.
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 13 Aug 2024.