Alveolar Ridge PreservationNCT04296682
Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction.
A study testing Alveolar Ridge Preservation With Gingival Graft in people with Alveolar Ridge Preservation and Connective Tissue, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Alveolar preservation seek to avoid multiple surgical interventions to the patient and decrease costs to the patient. In particular, in a Brazilian population where the need for extraction is great, the development of techniques that safely allow a higher quality of rehabilitation is of paramount importance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation, Connective Tissue
- What is being tested?
- Alveolar Ridge Preservation With Gingival 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
- 20 Jan 2020to 21 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemic health (absence of Hypertension and Diabetes);
- Indication of dental extraction of at least 2 teeth (with at least 2/3 of bone support, in the region of premolars or molars with indication for extraction;
- Signature of the consent form;
- Individuals over 18 years old.
Who cannot join
- Presence of periodontal disease at the time of surgery;
- Pregnant and lactating women;
- Smokers;
- Be under orthodontic treatment;
- Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonates group;
- Individuals under 18 years old.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Campinas, UNICAMP
Piracicaba, São Paulo, 13414-903
Renato CV Casarin, Prof. Dr., +55192106-5394, casarinrcv@yahoo.com.br
About this study
Official title: Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction: A Randomized Controlled Trial
Alveolar preservation seek to avoid multiple surgical interventions to the patient and decrease costs to the patient. In particular, in a Brazilian population where the need for extraction is great, the development of techniques that safely allow a higher quality of rehabilitation is of paramount importance. Thus, this analysis is of great scientific and therapeutic importance. Within the above, the objective is to use an autogenous connective tissue graft in order to eliminate the need to raise the full-thickness flap and compensate for soft tissue deficiencies, which may reduce dimensional losses after extraction, in addition to reducing the cost of the technique.
- Conditions
- Alveolar Ridge Preservation, Connective Tissue
- Being tested
- Alveolar Ridge Preservation With Gingival Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge Preservation With Gingival GraftProcedure or surgery
Closure of the alveolus with the placement of a free gingival tissue graft removed from the individual palate.
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Extraction Without Gingival Graft | No intervention | Alveolar closure with elevation of total flaps and simple suture (Silk thread 4.0, Ethicon, Johnson \& Johnson, SJC). |
| Atraumatic Extraction With Gingival Graft | Experimental | Closure of the alveolus without flap elevation, and placement of a free gingival tissue graft removed from the individual palate. Receives: Procedure: Alveolar Ridge Preservation With Gingival Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minor Alveolar dimensional loss with gingival graft.
Horizontal and vertical bone loss measures after CBCT base and 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start20 Jan 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion21 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Casarin, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296682
- Sponsor's protocol ID
- 13838819.1.0000.5418
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 6 Mar 2020
- 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04296682
- Acronym / sponsor ID
- 13838819.1.0000.5418
- Conditions
- Alveolar Ridge Preservation, Connective Tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 21 Dec 2020 (estimated)
- First posted
- 5 Mar 2020 (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.
Alveolar preservation seek to avoid multiple surgical interventions to the patient and decrease costs to the patient. In particular, in a Brazilian population where the need for extraction is great, the development of techniques that safely allow a higher quality of rehabilitation is of paramount importance. Thus, this analysis is of great scientific and therapeutic importance. Within the above, the objective is to use an autogenous connective tissue graft in order to eliminate the need to raise the full-thickness flap and compensate for soft tissue deficiencies, which may reduce dimensional losses after extraction, in addition to reducing the cost of the technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Extraction Without Gingival Graft | No intervention | –Alveolar closure with elevation of total flaps and simple suture (Silk thread 4.0, Ethicon, Johnson \& Johnson, SJC). |
| Atraumatic Extraction With Gingival Graft | Experimental | Procedure: Alveolar Ridge Preservation With Gingival GraftClosure of the alveolus without flap elevation, and placement of a free gingival tissue graft removed from the individual palate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systemic health (absence of Hypertension and Diabetes);
- Indication of dental extraction of at least 2 teeth (with at least 2/3 of bone support, in the region of premolars or molars with indication for extraction;
- Signature of the consent form;
- Individuals over 18 years old.
Key exclusion criteria (6 listed)
- Presence of periodontal disease at the time of surgery;
- Pregnant and lactating women;
- Smokers;
- Be under orthodontic treatment;
- Use medication that alters the bone healing process, such as those used to treat osteoporosis and the bisphosphonates group;
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 |
|---|---|---|
| Alveolar Ridge Preservation With Gingival GraftClosure of the alveolus with the placement of a free gingival tissue graft removed from the individual palate. | Procedure or surgery | Atraumatic Extraction With Gingival Graft |
Primary outcome
Minor Alveolar dimensional loss with gingival graft.
Time frame: 3 months
Horizontal and vertical bone loss measures after CBCT base and 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar Ridge Preservation With Gingival Graft in people with Alveolar Ridge Preservation and Connective Tissue, run by University of Campinas, Brazil 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 6 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 6 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minor Alveolar dimensional loss with gingival graft. (time frame: 3 months). 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 6 Mar 2020; AzTrials last refreshed its copy on 1 Nov 2026.