Xenograft ModelNCT04980313
Effect of Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Implants.
A study testing Xenogenic collagen matrix and Autogenous connective tissue graft in people with Xenograft Model, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Xenograft Model
- What is being tested?
- Xenogenic collagen matrix and Autogenous connective tissue graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 27 Apr 2021to Apr 2023
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adequate oral hygiene (21).
- Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion.
- Presence of adjacent teeth. Only one tooth gap.
- Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007
- Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).
Who cannot join
- Patients with medical conditions that affect bone and soft tissue metabolism.
- Uncontrolled endocrine disorders.
- Alcohol and drug abuse.
- Previous history of immunodeficiency syndromes.
- Patients who smoke> 10 cigarettes a day.
- Active periodontal disease.
Show all 11Show fewer
- Absence of a tooth adjacent to the tooth to be treated.
- Oral lesions of the untreated mucosa.
- Recent previous history (<6 months) of local radiotherapy or chemotherapy.
- Bruxism or severe parafunctions.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinica Dental Ortiz-Puigpelat
Barcelona, 08028
Octavi Ortiz-Puigpelat, +34629831138, octavi_ortiz@hotmail.com
About this study
Official title: Effect of a Volumetrically Stable Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Post-extraction Implants: a Randomized Controlled Clinical Study.
The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.
- Conditions
- Xenograft Model
- Being tested
- Xenogenic collagen matrix, Autogenous connective tissue graft
- Keywords
- immediate dental implants, dental extraction, alveolar socket, connective tissue graft, xenogenic collagen matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogenic collagen matrixDevice
Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
Autogenous connective tissue graftDevice
Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
| Study group | Role | What they receive |
|---|---|---|
| Xenogenic collagen matrix | Experimental | Volumetrically stable xenogenic collagen matrix Receives: Device: Xenogenic collagen matrix |
| Autogenous connective tissue graft | Active comparator | Autogenous connective tissue graft obtained from the tuberosity area Receives: Device: Autogenous connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the volumetric dimensional changes between the test and the control group
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
Measured: At T0(initial) before extraction
Analyze the volumetric dimensional changes between the test and the control group
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
Measured: At T6 (6 months after extraction)
Analyze the volumetric dimensional changes between the test and the control group
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
Measured: At T12 (12 months after extraction).
Secondary outcomes (15)
Analyze the mid-vestibular gingival level of the treated tooth.
Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in milimeters.
Measured: At T0(initial) before extraction
Analyze the mid-vestibular gingival level of the treated tooth.
Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in milimeters.
Measured: At T6 (6 months after extraction)
Analyze the mid-vestibular gingival level of the treated tooth.
Analyze the mid-vestibular gingival level of the treated tooth between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) with the use of periodontal probe in milimeters.
Measured: At T12 (12 months after extraction).
Measure the band of keratinized tissue around the treated tooth
Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters.
Measured: At T0(initial) before extraction
Measure the band of keratinized tissue around the treated tooth
Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters.
Measured: At T6 (6 months after extraction)
Measure the band of keratinized tissue around the treated tooth
Measure the band of keratinized tissue around the treated tooth with the use of a periodontal probe in milimeters.
Measured: At T12 (12 months after extraction).
Assessment of pain during surgery in both groups
Assessment of pain during surgery between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) using a numeric scale from 0 to 10, being 0 absence of pain and 10 worst possibble pain.
Measured: At the day of the surgery
Assessment of pain during surgery in both groups
Assessment of pain during surgery between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) using a numeric scale from 0 to 10, being 0 absence of pain and 10 worst possibble pain.
Measured: After 10 days after surgery
Quantification of the analgesic medication intake by patients in both groups
Quantification of the analgesic medication intake by patients in both groups after 10 days of the surgery. Type of analgesic/antiinflmatory medication and number of pills/day
Measured: At 10 days after the surgery.
Comparison of the total surgical time used in each group.
Measure the time needed for the suergery express in: hh/mm/ss
Measured: At the day of the surgery
Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application.
Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application. Expressed in € per each surgery.
Measured: At the day of the surgery
Analyze patient satisfaction between groups
Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions.
Measured: At T0 before extraction.
Analyze patient satisfaction between groups
Analyze patient satisfaction between groups with the use of a modified Oral Health Impact Profile Questionnaire consisting of 14 questions.
Measured: At T12 (12 months after the extraction).
Analysis of possible complications in both groups.
Record the number of complications and also a descriptive analysis of the different types of complications.
Measured: They will be reported anytime during the study
Evaluation of implant success in both groups at one year of follow-up
Evaluation of implant success in both groups at one year of follow-up, expressed in the difference in milimeters of the periimplant bone loss.
Measured: At T12 (12 months after the extraction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start27 Apr 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xenograft ModelStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Octavi Ortiz Puigpelat, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980313
- Sponsor's protocol ID
- CIR-ELC-2021-01
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Volumetrically Stable Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Post-extraction Implants: a Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT04980313
- Acronym / sponsor ID
- CIR-ELC-2021-01
- Conditions
- Xenograft Model
- Keywords
- immediate dental implants, dental extraction, alveolar socket, connective tissue graft, xenogenic collagen matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 28 Jul 2021 (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 present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenogenic collagen matrix | Experimental | Device: Xenogenic collagen matrixVolumetrically stable xenogenic collagen matrix |
| Autogenous connective tissue graft | Active comparator | Device: Autogenous connective tissue graftAutogenous connective tissue graft obtained from the tuberosity area |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adequate oral hygiene (21).
- Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion.
- Presence of adjacent teeth. Only one tooth gap.
- Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007
- Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).
Key exclusion criteria (11 listed)
- Patients with medical conditions that affect bone and soft tissue metabolism.
- Uncontrolled endocrine disorders.
- Alcohol and drug abuse.
- Previous history of immunodeficiency syndromes.
- Patients who smoke> 10 cigarettes a day.
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 |
|---|---|---|
| Xenogenic collagen matrixUse of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets. | Device | Xenogenic collagen matrix |
| Autogenous connective tissue graftUse of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets. | Device | Autogenous connective tissue graft |
Primary outcome
Analyze the volumetric dimensional changes between the test and the control group
Time frame: At T0(initial) before extraction
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
Analyze the volumetric dimensional changes between the test and the control group
Time frame: At T6 (6 months after extraction)
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
Analyze the volumetric dimensional changes between the test and the control group
Time frame: At T12 (12 months after extraction).
Analyze the volumetric dimensional changes between the test (xenogeneic collagen matrix) and the control group (autogenous connective tissue graft) in mm3.
15 secondary outcomes
Analyze the mid-vestibular gingival level of the treated tooth.
Time frame: At T0(initial) before extraction
Analyze the mid-vestibular gingival level of the treated tooth.
Time frame: At T6 (6 months after extraction)
Analyze the mid-vestibular gingival level of the treated tooth.
Time frame: At T12 (12 months after extraction).
Measure the band of keratinized tissue around the treated tooth
Time frame: At T0(initial) before extraction
Measure the band of keratinized tissue around the treated tooth
Time frame: At T6 (6 months after extraction)
Measure the band of keratinized tissue around the treated tooth
Time frame: At T12 (12 months after extraction).
Assessment of pain during surgery in both groups
Time frame: At the day of the surgery
Assessment of pain during surgery in both groups
Time frame: After 10 days after surgery
Quantification of the analgesic medication intake by patients in both groups
Time frame: At 10 days after the surgery.
Comparison of the total surgical time used in each group.
Time frame: At the day of the surgery
Comparison of the economic costs for each patient in the collection of the autologous graft and its application versus the purchase of the Fibrogide and its application.
Time frame: At the day of the surgery
Analyze patient satisfaction between groups
Time frame: At T0 before extraction.
Analyze patient satisfaction between groups
Time frame: At T12 (12 months after the extraction).
Analysis of possible complications in both groups.
Time frame: They will be reported anytime during the study
Evaluation of implant success in both groups at one year of follow-up
Time frame: At T12 (12 months after the extraction)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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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 Xenogenic collagen matrix and Autogenous connective tissue graft in people with Xenograft Model, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 5 inclusion and 11 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 28 Jul 2021. 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 Spain. 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 Octavi Ortiz-Puigpelat, DDS, PhD (+34629831138, octaviortiz@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the volumetric dimensional changes between the test and the control group (time frame: At T0(initial) before extraction). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021.