Implant Tissue FailureNCT06206499
Laterally Rotated Flap for Soft Tissue Augmentation Around Maxillary Loaded Osseointegrated Dental Implant
A study testing soft tissue augmentation in people with Implant Tissue Failure and Dental Implant Failed, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Peri-implant mucositis is one of the most common peri-implant diseases. It was reported in more than 20% of the subjects rehabilitated with dental implants (Lee et al. 2017; Rodrigo et al. 2018; Wada et al. 2019). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implant Tissue Failure, Dental Implant Failed, Peri-Implantitis
- What is being tested?
- soft tissue augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2024to 29 Oct 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- implant with soft tissue recession Plaque index score less than 30% No relevant systemic disease Smokers (Less than 20 cigars/day)
Who cannot join
- Pregnancy-Lactation Relevant systemic disease
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Murcia
Murcia, 30009
MIGUEL RAMON P PECCI LLORET, PhD, 630492610, miguelr.pecci@gmail.com
About this study
Peri-implant mucositis is one of the most common peri-implant diseases. It was reported in more than 20% of the subjects rehabilitated with dental implants (Lee et al. 2017; Rodrigo et al. 2018; Wada et al. 2019). Furthermore, a significant association was found between peri-implant mucositis, and smoking, implant maintenance and peri-implant soft tissue characteristics (Wada et al. 2019).
Soft tissue quality and volume of the peri-implant mucosa are considered important factors in the prognosis of osseointegrated implants. Linkevicius et al. showed that if its soft tissue thickness was less than 2 mm, crestal bone loss might occur (Linkevicius et al. 2009). In addition, when soft tissue width was evaluated, a wider soft tissue band was related to minimal bone remodeling (Linkevicius et al. 2015). Lin et al. reported in a systematic review and meta-analysis that a lack of keratinized tissue (KT) around osseintegrated implants was associated with plaque accumulation, peri-implant tissue inflammation, soft tissue recession and attachment loss (Lin et al. 2013). Moreover, recent studies established the need of a minimal band of 2 mm of KT around osseointegrated implants, and showed that a band less than 2 mm was associated with more brushing discomfort, plaque accumulation, tissue inflammation and marginal bone apical displacement, concluding that a KT>2 mm had a protective effect on peri-implant tissues (Souza et al. 2015, Perussolo et al. 2018, Monje et al. 2019). Furthermore, peri-implant tissue diseases have also been related to an irregular compliance in situations of lack of KT (Monje et al. 2019).
In the presence of peri-implant horizontal and/or vertical soft tissue deficiencias, soft tissue augmentation has been considered a priority, even prior or instead of bone augmentation (Burkhardt et al. 2008, Zucchelli et al. 2013).
- Being tested
- soft tissue augmentation
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue augmentationProcedure or surgery
Laterally Rotated Flap: A Split-thickness recipient bed on the buccal and mesial aspects of the implant was prepared, resulting in a firm attached bleeding area. The extension of the incisions towards the palate and the distance between them are dependent on the amount of keratinized tissue graft needed for each particular case. Habitually, the keratinized tissue is taken from the adjacent crest; however, if needed to displace more tissue, the incisions may be extended into the palatal tissue. The flap was prepared partial thickness, and released apically from the periosteum to allow passive displacement, and suturing without tension. It was latero-mesially displaced with a 90º rotation. The pedicle was sutured to the recipient bed.
Control group: The surgical procedure followed the design proposed by Sullivans \& Atkins 1968 for soft tissue augmentation around teeth and modified by for application around oseointegrated dental implants.
| Study group | Role | What they receive |
|---|---|---|
| Laterally Rotated Flap | Experimental | LRF, Moreno and Caffesse, 2016 Receives: Procedure: soft tissue augmentation |
| Free gingival graft | Active comparator | FGG, Sullivan and Atkins, 1968, Langer and Sullivan, 1989 Receives: Procedure: soft tissue augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in soft tissue 6months after procedure
The amount of soft tissue gained in millimeters will be measured before and after
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start4 Apr 2024 (estimated)
- Primary completion29 Sep 2024 (estimated)
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Tissue FailureStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Rodriguez Lozano, Universidad de Murcia
- Investigators
- JOSE ANTONIO MORENO RODRÍGUEZ, DDS, Principal investigator, UNIVERSIDAD DE MURCAI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206499
- Sponsor's protocol ID
- 2586/2019
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laterally Rotated Flap for Soft Tissue Augmentation Around Maxillary Loaded Osseointegrated Dental Implant
- ClinicalTrials.gov ID
- NCT06206499
- Acronym / sponsor ID
- 2586/2019
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 4 Apr 2024 (estimated)
- Primary completion
- 29 Sep 2024 (estimated)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 16 Jan 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.
Peri-implant mucositis is one of the most common peri-implant diseases. It was reported in more than 20% of the subjects rehabilitated with dental implants (Lee et al. 2017; Rodrigo et al. 2018; Wada et al. 2019). Furthermore, a significant association was found between peri-implant mucositis, and smoking, implant maintenance and peri-implant soft tissue characteristics (Wada et al. 2019).
Soft tissue quality and volume of the peri-implant mucosa are considered important factors in the prognosis of osseointegrated implants. Linkevicius et al. showed that if its soft tissue thickness was less than 2 mm, crestal bone loss might occur (Linkevicius et al. 2009). In addition, when soft tissue width was evaluated, a wider soft tissue band was related to minimal bone remodeling (Linkevicius et al. 2015). Lin et al. reported in a systematic review and meta-analysis that a lack of keratinized tissue (KT) around osseintegrated implants was associated with plaque accumulation, peri-implant tissue inflammation, soft tissue recession and attachment loss (Lin et al. 2013). Moreover, recent studies established the need of a minimal band of 2 mm of KT around osseointegrated implants, and showed that a band less than 2 mm was associated with more brushing discomfort, plaque accumulation, tissue inflammation and marginal bone apical displacement, concluding that a KT>2 mm had a protective effect on peri-implant tissues (Souza et al. 2015, Perussolo et al. 2018, Monje et al. 2019). Furthermore, peri-implant tissue diseases have also been related to an irregular compliance in situations of lack of KT (Monje et al. 2019).
In the presence of peri-implant horizontal and/or vertical soft tissue deficiencias, soft tissue augmentation has been considered a priority, even prior or instead of bone augmentation (Burkhardt et al. 2008, Zucchelli et al. 2013).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laterally Rotated Flap | Experimental | Procedure: soft tissue augmentationLRF, Moreno and Caffesse, 2016 |
| Free gingival graft | Active comparator | Procedure: soft tissue augmentationFGG, Sullivan and Atkins, 1968, Langer and Sullivan, 1989 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- implant with soft tissue recession Plaque index score less than 30% No relevant systemic disease Smokers (Less than 20 cigars/day)
Key exclusion criteria (1 listed)
- Pregnancy-Lactation Relevant systemic disease
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 |
|---|---|---|
| soft tissue augmentationLaterally Rotated Flap: A Split-thickness recipient bed on the buccal and mesial aspects of the implant was prepared, resulting in a firm attached bleeding area. The extension of the incisions towards the palate and the distance between them are dependent on the amount of keratinized tissue graft needed for each particular case. Habitually, the keratinized tissue is taken from the adjacent crest; however, if needed to displace more tissue, the incisions may be extended into the palatal tissue. The flap was prepared partial thickness, and released apically from the periosteum to allow passive displacement, and suturing without tension. It was latero-mesially displaced with a 90º rotation. The pedicle was sutured to the recipient bed. Control group: The surgical procedure followed the design proposed by Sullivans \& Atkins 1968 for soft tissue augmentation around teeth and modified by for application around oseointegrated dental implants. | Procedure or surgery | Free gingival graft, Laterally Rotated Flap |
Primary outcome
Change in soft tissue 6months after procedure
Time frame: 1 year
The amount of soft tissue gained in millimeters will be measured before and after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
JOSE ANTONIO MORENO RODRÍGUEZ, DDS principal investigator
UNIVERSIDAD DE MURCAI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft tissue augmentation in people with Implant Tissue Failure and Dental Implant Failed, run by Universidad de Murcia 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 1 inclusion and 1 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 16 Jan 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 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 MIGUEL RAMÓN P PECCI LLORET, PhD (630492610, miguelr.pecci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in soft tissue 6months after procedure (time frame: 1 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 16 Jan 2024.