MucositisNCT04628520
Surgical Protocol for Prevention of Mucositis
A study testing Free gingival graft, Collagen matrix and Maintenance in people with Mucositis, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
The main goal of implant therapy is to obtain long-term peri-implant health. Among local risk factors in the etiology of peri-implant diseases the absence of keratinized tissue (KT) around the implant has been reported. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucositis
- What is being tested?
- Free gingival graft, Collagen matrix and Maintenance
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2018to 30 Dec 2021
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemic healthy patients
- appropriate oral hygiene standards (full mouth plaque scores <20%)
- periodontal health (BoP < 10%) or gingivitis (BoP > 10%) in a healthy or reduced periodontium
- clinical signs of mucositis (presence of BoP) at the affected implant-supported fixed prosthesis
- < 2mm of KT at the mid-buccal aspect of implant-supported fixed prosthesis
- < 10 cigarette/die
Who cannot join
- any systemic disease that would negatively influence wound healing or known allergy to collagen
- more than 10 cigarettes/day
- sites with implant-supported rehabilitations presenting poor marginal adaptation (confirmed by an explorative probe and radiographic examination)
- implant-supported rehabilitations with inadequate access to hygiene
Trial locations and contacts
1 site in 1 country.
Massimo De Sanctis contact
Italy1 site, 1 recruiting
- Recruiting
Università Vita-Salute San Raffaele
Milan, 20100
Marco Clementini
About this study
Official title: Effect of Soft Tissue Augmentation Procedures on Peri-implant Health
The main goal of implant therapy is to obtain long-term peri-implant health. Among local risk factors in the etiology of peri-implant diseases the absence of keratinized tissue (KT) around the implant has been reported. In fact, a certain amount of KT width, providing better sensory isolation and, hence, less pain discomfort during brushing, may be useful to facilitate plaque control. A good plaque control should maintain periimplant health during time.
A very recent systematic review assessed the effect of soft tissue grafting procedures on peri-implant health, revealing that soft tissue grafting using autogenous tissue for gain of KT results in a significant decrease of PI, BOP and GI values and significantly lower PI and GI values and higher marginal bone levels at the study endpoint compared to maintenance groups.
Read the detailed description
Based in the available data in literature, it has been demonstrated that the level of brushing discomfort was significantly higher in sites with <2 mm of KT width, which exhibited more plaque and more bleeding on probing than sites with ≥2 mm of KT width. Therefore, various procedures and materials were proposed in the past to augment the soft tissues around dental implant. Soft-tissue grafting seems beneficial, especially in posterior mandible, when patients complains of soreness during oral hygiene procedures and plaque control is less than ideal and it may be facilitated by a better topography. The surgical procedures most frequently used to increase the width of keratinized tissue around an implant-supported restoration include an apically positioned split-flap/vestibuloplasty (APF) with or without the application of autogenous tissue (i.e., free gingival graft) or a xenogeneic collagen matrix.
However, it remains unclear whether or not surgical procedures for gain of KT may establish peri-implant health limiting the incidence of peri-implant disease and may positively affect self-performed oral hygiene measures reducing peri-implant soft tissue inflammation when compared with non-augmented, inadequately dimensioned implant sites. Neither do clinical suggestions exist for a specific soft tissue transplant to obtain more favorable outcomes.
The aim of the present randomized controlled clinical trial is to assess the effect of soft tissue augmentation procedures at diseased (mucositis) implant sites in terms of:
- occurrence of peri-implant health (absence of BoP/suppuration, PPD>6mm, longitudinal radiographic bone loss) at 3, 6 and 12 months
- reduction of BoP (%) at 3, 6 and 12 months
- marginal bone loss (MBL) at 12 months
- improvement of self-performed oral hygiene measures (PI, VAS) at 3, 6 and 12 months and post-operative morbidity (VAS) at 7 days.
- change in tissue morphology: increase of KT width (2D in mm.) and tissue volume (volumetric 3D) at 3, 6 and 12 months and aesthetic (blinder examiner) at 6, 12 months.
- Conditions
- Mucositis
- Being tested
- Free gingival graft, Collagen matrix, Maintenance
- Keywords
- CTG, Mucositis, Surgical Treatment, Keratinised tissue, Free gingival graft, Collagen matrix
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graftProcedure or surgery
After administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive a free gingival graft (FGG) harvested from the palate, that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment.
Collagen matrixProcedure or surgery
After administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive either a collagen matrix (CM), that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment.
MaintenanceProcedure or surgery
Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy
| Study group | Role | What they receive |
|---|---|---|
| Maintenance | Sham comparator | Oral hygiene instruction and periodontal maintenance Receives: Procedure: Maintenance |
| Free gingival graft | Active comparator | After administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive a free gingival graft (FGG) harvested from the palate, that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment. Receives: Procedure: Free gingival graft; Procedure: Maintenance |
| Collagen matrix | Active comparator | After administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive either a collagen matrix (CM), that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment. Receives: Procedure: Collagen matrix; Procedure: Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant health occurrence
percentages of clinical cases with the following characteristics for each treated implant: absence of Bleeding on Probing (BoP), Probing Pocket Depth (PPD) <6mm, absence of marginal bone loss (MBL)
Measured: 6 and 12 months after treatment
Secondary outcomes (10)
Bleeding on probing (BoP) changes
changes of bleeding on probing, evaluated as present if bleeding will be evident within 15 s after gentle probing, or absent, if no bleeding will be noticed within 15 s after probing
Measured: 3, 6 and 12 months after treatment
Plaque index (PI) changes
changes in plaque index, evaluated as present if identifiable plaque will be evident, with the use of a periodontal probe along the gingival margin, or absent, if no plaque will be noticed
Measured: 3, 6 and 12 months after treatment
Probing pocket depth (PPD) changes
changes in probing pocket depth, assessed from the peri-implant mucosa margin to the the bottom of the peri-implant sulcus, measured in millimeters
Measured: 3, 6 and 12 months after treatment
mucosal recession (REC) changes
changes in mucosal recession, assessed from the implant shoulder to the peri-implant mucosa margin, measured in millimeters
Measured: 3, 6 and 12 months after treatment
Keratinized tissue changes ( KT)
width of KT, assessed from the gingival margin to the mucogingival junction at the mid-buccal aspect of the implant measured through "rolling technique" in millimeters
Measured: 3, 6 and 12 months after treatment
marginal bone loss (MBL)
marginal bone loss at mesial and distal aspect, measured on periapical X-ray
Measured: 6 and 12 months after treatment
discomfort during oral hygiene procedure
the level of brushing discomfort experienced by patients during oral hygiene will be evaluated, using a 0 to 100 mm visual analog scale (VAS). Patients will be invited to mark a point in the line that will represent the level of discomfort they felt during the brushing procedure, varying from 0 (no discomfort) to 100 (extreme discomfort).
Measured: baseline, 3, 6 and 12 months after treatment
post-surgical morbidity
the level of post-operative morbidity will be evaluated through a 0 to 100 mm visual analog scale (VAS) and the amount of anti-inflammatory medication used by the patient. The investigator will record the presence of complications, additional treatments, and medication in connection to the surgical treatment, using a specific form and a questionnaire handed to the patients.
Measured: 7 days after treatment
volumetric changes
digital impressions will be obtained using a 3D scanner in order to create stereolithography (STL) files. STL files of each patient will be superimposed and matched using a digital volume comparison software program. Superimposed STL files will be used to assess linear and volumetric soft tissue dimensional changes (linear and volumetric soft tissue contour changes).
Measured: 3, 6 and 12 months after treatment
aesthetic
aesthetic will be evaluated by a blinder examiner with the pink esthetic score (PES) as described by Fürhauser et al. 2005
Measured: 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start2 Jul 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies 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
- Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Clementini, Università Vita-Salute San Raffaele
- Investigators
- Massimo De Sanctis, Study chair, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628520
- Sponsor's protocol ID
- Mucositis surgical
- Status last verified
- Nov 2020
- First submitted
- 31 Oct 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soft Tissue Augmentation Procedures on Peri-implant Health
- ClinicalTrials.gov ID
- NCT04628520
- Acronym / sponsor ID
- Mucositis surgical
- Conditions
- Mucositis
- Keywords
- CTG, Mucositis, Surgical Treatment, Keratinised tissue, Free gingival graft, Collagen matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Nov 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.
The main goal of implant therapy is to obtain long-term peri-implant health. Among local risk factors in the etiology of peri-implant diseases the absence of keratinized tissue (KT) around the implant has been reported. In fact, a certain amount of KT width, providing better sensory isolation and, hence, less pain discomfort during brushing, may be useful to facilitate plaque control. A good plaque control should maintain periimplant health during time.
A very recent systematic review assessed the effect of soft tissue grafting procedures on peri-implant health, revealing that soft tissue grafting using autogenous tissue for gain of KT results in a significant decrease of PI, BOP and GI values and significantly lower PI and GI values and higher marginal bone levels at the study endpoint compared to maintenance groups.
Detailed description
Based in the available data in literature, it has been demonstrated that the level of brushing discomfort was significantly higher in sites with <2 mm of KT width, which exhibited more plaque and more bleeding on probing than sites with ≥2 mm of KT width. Therefore, various procedures and materials were proposed in the past to augment the soft tissues around dental implant. Soft-tissue grafting seems beneficial, especially in posterior mandible, when patients complains of soreness during oral hygiene procedures and plaque control is less than ideal and it may be facilitated by a better topography. The surgical procedures most frequently used to increase the width of keratinized tissue around an implant-supported restoration include an apically positioned split-flap/vestibuloplasty (APF) with or without the application of autogenous tissue (i.e., free gingival graft) or a xenogeneic collagen matrix.
However, it remains unclear whether or not surgical procedures for gain of KT may establish peri-implant health limiting the incidence of peri-implant disease and may positively affect self-performed oral hygiene measures reducing peri-implant soft tissue inflammation when compared with non-augmented, inadequately dimensioned implant sites. Neither do clinical suggestions exist for a specific soft tissue transplant to obtain more favorable outcomes.
The aim of the present randomized controlled clinical trial is to assess the effect of soft tissue augmentation procedures at diseased (mucositis) implant sites in terms of:
- occurrence of peri-implant health (absence of BoP/suppuration, PPD>6mm, longitudinal radiographic bone loss) at 3, 6 and 12 months
- reduction of BoP (%) at 3, 6 and 12 months
- marginal bone loss (MBL) at 12 months
- improvement of self-performed oral hygiene measures (PI, VAS) at 3, 6 and 12 months and post-operative morbidity (VAS) at 7 days.
- change in tissue morphology: increase of KT width (2D in mm.) and tissue volume (volumetric 3D) at 3, 6 and 12 months and aesthetic (blinder examiner) at 6, 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maintenance | Sham comparator | Procedure: MaintenanceOral hygiene instruction and periodontal maintenance |
| Free gingival graft | Active comparator | Procedure: Free gingival graft, Procedure: MaintenanceAfter administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive a free gingival graft (FGG) harvested from the palate, that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment. |
| Collagen matrix | Active comparator | Procedure: Collagen matrix, Procedure: MaintenanceAfter administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive either a collagen matrix (CM), that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Systemic healthy patients
- appropriate oral hygiene standards (full mouth plaque scores <20%)
- periodontal health (BoP < 10%) or gingivitis (BoP > 10%) in a healthy or reduced periodontium
- clinical signs of mucositis (presence of BoP) at the affected implant-supported fixed prosthesis
- < 2mm of KT at the mid-buccal aspect of implant-supported fixed prosthesis
Key exclusion criteria (4 listed)
- any systemic disease that would negatively influence wound healing or known allergy to collagen
- more than 10 cigarettes/day
- sites with implant-supported rehabilitations presenting poor marginal adaptation (confirmed by an explorative probe and radiographic examination)
- implant-supported rehabilitations with inadequate access to hygiene
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 |
|---|---|---|
| Free gingival graftAfter administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive a free gingival graft (FGG) harvested from the palate, that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment. | Procedure or surgery | Free gingival graft |
| Collagen matrixAfter administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive either a collagen matrix (CM), that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment. | Procedure or surgery | Collagen matrix |
| MaintenanceOral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy | Procedure or surgery | Collagen matrix, Free gingival graft, Maintenance |
Primary outcome
peri-implant health occurrence
Time frame: 6 and 12 months after treatment
percentages of clinical cases with the following characteristics for each treated implant: absence of Bleeding on Probing (BoP), Probing Pocket Depth (PPD) <6mm, absence of marginal bone loss (MBL)
10 secondary outcomes
Bleeding on probing (BoP) changes
Time frame: 3, 6 and 12 months after treatment
Plaque index (PI) changes
Time frame: 3, 6 and 12 months after treatment
Probing pocket depth (PPD) changes
Time frame: 3, 6 and 12 months after treatment
mucosal recession (REC) changes
Time frame: 3, 6 and 12 months after treatment
Keratinized tissue changes ( KT)
Time frame: 3, 6 and 12 months after treatment
marginal bone loss (MBL)
Time frame: 6 and 12 months after treatment
discomfort during oral hygiene procedure
Time frame: baseline, 3, 6 and 12 months after treatment
post-surgical morbidity
Time frame: 7 days after treatment
volumetric changes
Time frame: 3, 6 and 12 months after treatment
aesthetic
Time frame: 6 and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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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.
Massimo De Sanctis contact
Massimo De Sanctis study chair
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free gingival graft, Collagen matrix and Maintenance in people with Mucositis, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 6 inclusion and 4 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 Nov 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 Italy. 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. Some participants in this study may receive a placebo. 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 Marco Clementini (0226432806, mclementini@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri-implant health occurrence (time frame: 6 and 12 months after treatment). 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 13 Nov 2020.