Surgical Protocol for Prevention of Mucositis
Effect of Soft Tissue Augmentation Procedures on Peri-implant Health
1 other identifier
interventional
51
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2018
CompletedFirst Submitted
Initial submission to the registry
October 31, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedNovember 13, 2020
November 1, 2020
3.5 years
October 31, 2020
November 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
6 and 12 months after treatment
Secondary Outcomes (10)
Bleeding on probing (BoP) changes
3, 6 and 12 months after treatment
Plaque index (PI) changes
3, 6 and 12 months after treatment
Probing pocket depth (PPD) changes
3, 6 and 12 months after treatment
mucosal recession (REC) changes
3, 6 and 12 months after treatment
Keratinized tissue changes ( KT)
3, 6 and 12 months after treatment
- +5 more secondary outcomes
Study Arms (3)
Maintenance
SHAM COMPARATOROral hygiene instruction and periodontal maintenance
Free gingival graft
ACTIVE COMPARATORAfter 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 COMPARATORAfter 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.
Interventions
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.
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.
Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Università Vita-Salute San Raffaele
Milan, 20100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Massimo De Sanctis
Università Vita-Salute San Raffaele
Central Study Contacts
Massimo De Sanctis
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 31, 2020
First Posted
November 13, 2020
Study Start
July 2, 2018
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
November 13, 2020
Record last verified: 2020-11