Recession, GingivalNCT03106506
Influence of Connective Tissue Graft Around Implants
A study testing Connective tissue graft in people with Recession, Gingival, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The objective of this randomized controlled clinical study was to evaluate the increase in the volume of peri-implant gingival tissue in implants installed in the aesthetic areas with the use of subepithelial-conjunctive tissue graft, and a sample of 40 individuals with implants Aesthetics where the test group (n =… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- Connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Mar 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients at least 20 years of age systemically healthy , oral hygiene satisfactory,assessed by plaque index Gingival Index and less than 25% (O'Leary et al. 1972).
- Patient requiring one implant in the anterior maxilla (premolar of the premolar).
- Availability of healthy bone tissue or greater than five millimeters, with the view to greater primary stability or equal to 35 Ncm
- agreed to participate in the study and sign a written consent ( Resolution No. 196 of October 1996 and the Code of Professional Ethics Dental - C.F.O. - 179/93)
Who cannot join
- Smokers;
- Patients with parafunctional habits such as bruxism;
- Pregnant or lactating;
- Patients with systemic diseases uncontrolled (cardiovascular diseases, blood disorders, changes in bone metabolism, immunodeficiencies and diabetes) , contraindicate the surgical procedure.
- Drugs that interfere with wound healing, Drug Related gingival hyperplasia phenytoin (dantalin, dialudon, Epelin, fenital, phenytoin, phenytoin sodium, hidantal), cyclosporine A (Restasis, Sandimmun Neoral Sandimmunmicroral Sigmasporin), blockers of calcium channel, (bezilato of amilodipina hydrochloride, ditiaziem, felodipine, isradipine, lacidipine, lercadinipina hydrochloride, micardipina hydrochloride, nifedipine, risoldipina) Immunosuppressive drugs such as Azathioprine, and Prednisolone, drugs of the class of bisphosphonates(alendronate, zoledronate, ibandronate, risedronate, pamidronate, clodronate, etidronate and clodronate) that reduce the metabolism of osteoclasts , inhibiting bone metabolism;
- Implants in adjacent regions;
Show all 10Show fewer
- Sites of acute infections;
- Sites with large defects in the buccal bone wall;
- Requiring any sort of bone augmentation procedure;
- Patients in orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Connective Tissue Graft Placement on the Volume of Soft Tissue Around Implants Placed in Aesthetic Areas. Randomized Controlled Clinical Trial.
The objective of this randomized controlled clinical study was to evaluate the increase in the volume of peri-implant gingival tissue in implants installed in the aesthetic areas with the use of subepithelial-conjunctive tissue graft, and a sample of 40 individuals with implants Aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a tec graft. Epithelial-conjunctival.
Read the detailed description
Osseointegrated implants have been used since the mid-1950s, and countless studies have ensured the reliability of their use, so the implant has become a common practice among dental surgeons, as the use of implants has increased its complications as well. Accompany the same development, especially when they are installed in aesthetic areas, where deficiency of periimplant gingival tissue is insufficient.
The objective of this randomized controlled clinical study was to evaluate the increase in the volume of periimplant gingival tissue in implants installed in the aesthetic areas with the use of subepithelial conjunctive tissue graft, and a sample of 40 individuals with implants aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a tec graft epithelial conjunctival.
In order to analyze the increase of gingival periimplant tissue, pre, trans and postoperative clinical measurements, aesthetic evaluation, patient satisfaction assessment and improvement of the quality of life will be performed and the radiographic measurements will be performed to evaluate the periimplant bone structures and their influence on the results.
These measurements will be performed in the pre-operative (baseline), 6 months postoperatively and 6 months after installation of the definitive crown on the implant, the study will have a power of 80% (p = 0.05).
- Conditions
- Recession, Gingival
- Being tested
- Connective tissue graft
- Keywords
- Implants, Conjunctive tissue graft, Prospective study
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
Implant installation surgery with cone morse system with the concomitant placement of autogenous connective tissue.
| Study group | Role | What they receive |
|---|---|---|
| Test-implant with graft | Experimental | Patients who received a connective tissue graft around implants Receives: Procedure: Connective tissue graft |
| Control-Implant without graft | Active comparator | Implant installation surgery with cone morse system without the placement of connective tissue graft. Receives: Procedure: Connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain of peri-implant soft tissue
It is expected that the association of autogenous connective graft to the placement of cone-morse platform implants in aesthetic areas allows a greater gain of peri-implant soft tissue and better aesthetic results after the installation of definitive prostheses than in the other proposed groups.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startJun 2015
- Primary completionJul 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A sample of 40 individuals with esthetic need implants will be used for the study, where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a sub-epithelial-conjunctive tissue graft.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Maria Jardini, Doctor, Study director, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106506
- Sponsor's protocol ID
- f4vqwv6j
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Connective Tissue Graft Placement on the Volume of Soft Tissue Around Implants Placed in Aesthetic Areas. Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03106506
- Acronym / sponsor ID
- f4vqwv6j
- Conditions
- Recession, Gingival
- Keywords
- Implants, Conjunctive tissue graft, Prospective study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Apr 2017 (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 objective of this randomized controlled clinical study was to evaluate the increase in the volume of peri-implant gingival tissue in implants installed in the aesthetic areas with the use of subepithelial-conjunctive tissue graft, and a sample of 40 individuals with implants Aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a tec graft. Epithelial-conjunctival.
Detailed description
Osseointegrated implants have been used since the mid-1950s, and countless studies have ensured the reliability of their use, so the implant has become a common practice among dental surgeons, as the use of implants has increased its complications as well. Accompany the same development, especially when they are installed in aesthetic areas, where deficiency of periimplant gingival tissue is insufficient.
The objective of this randomized controlled clinical study was to evaluate the increase in the volume of periimplant gingival tissue in implants installed in the aesthetic areas with the use of subepithelial conjunctive tissue graft, and a sample of 40 individuals with implants aesthetics where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a tec graft epithelial conjunctival.
In order to analyze the increase of gingival periimplant tissue, pre, trans and postoperative clinical measurements, aesthetic evaluation, patient satisfaction assessment and improvement of the quality of life will be performed and the radiographic measurements will be performed to evaluate the periimplant bone structures and their influence on the results.
These measurements will be performed in the pre-operative (baseline), 6 months postoperatively and 6 months after installation of the definitive crown on the implant, the study will have a power of 80% (p = 0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A sample of 40 individuals with esthetic need implants will be used for the study, where the test group (n = 20) will receive tec graft. (N = 20) will receive only the dental implant without the placement of a sub-epithelial-conjunctive tissue graft.
| Arm | Type | Receives |
|---|---|---|
| Test-implant with graft | Experimental | Procedure: Connective tissue graftPatients who received a connective tissue graft around implants |
| Control-Implant without graft | Active comparator | Procedure: Connective tissue graftImplant installation surgery with cone morse system without the placement of connective tissue graft. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at least 20 years of age systemically healthy , oral hygiene satisfactory,assessed by plaque index Gingival Index and less than 25% (O'Leary et al. 1972).
- Patient requiring one implant in the anterior maxilla (premolar of the premolar).
- Availability of healthy bone tissue or greater than five millimeters, with the view to greater primary stability or equal to 35 Ncm
- agreed to participate in the study and sign a written consent ( Resolution No. 196 of October 1996 and the Code of Professional Ethics Dental - C.F.O. - 179/93)
Key exclusion criteria (10 listed)
- Smokers;
- Patients with parafunctional habits such as bruxism;
- Pregnant or lactating;
- Patients with systemic diseases uncontrolled (cardiovascular diseases, blood disorders, changes in bone metabolism, immunodeficiencies and diabetes) , contraindicate the surgical procedure.
- Drugs that interfere with wound healing, Drug Related gingival hyperplasia phenytoin (dantalin, dialudon, Epelin, fenital, phenytoin, phenytoin sodium, hidantal), cyclosporine A (Restasis, Sandimmun Neoral Sandimmunmicroral Sigmasporin), blockers of calcium channel, (bezilato of amilodipina hydrochloride, ditiaziem, felodipine, isradipine, lacidipine, lercadinipina hydrochloride, micardipina hydrochloride, nifedipine, risoldipina) Immunosuppressive drugs such as Azathioprine, and Prednisolone, drugs of the class of bisphosphonates(alendronate, zoledronate, ibandronate, risedronate, pamidronate, clodronate, etidronate and clodronate) that reduce the metabolism of osteoclasts , inhibiting bone metabolism;
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 |
|---|---|---|
| Connective tissue graftImplant installation surgery with cone morse system with the concomitant placement of autogenous connective tissue. | Procedure or surgery | Control-Implant without graft, Test-implant with graft |
Primary outcome
Gain of peri-implant soft tissue
Time frame: one year
It is expected that the association of autogenous connective graft to the placement of cone-morse platform implants in aesthetic areas allows a greater gain of peri-implant soft tissue and better aesthetic results after the installation of definitive prostheses than in the other proposed groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
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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.
Maria Jardini, Doctor study director
Universidade Estadual Paulista Júlio de Mesquita Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft in people with Recession, Gingival, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 10 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: finished, as of the sponsor's last update on 23 May 2017. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gain of peri-implant soft tissue (time frame: one year). 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 23 May 2017.