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Surgical Protocol for Prevention of Mucositis

NCT ID: NCT04628520

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2021-12-30

Brief Summary

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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

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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

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Mucositis

Keywords

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CTG Mucositis Surgical Treatment Keratinised tissue Free gingival graft Collagen matrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Maintenance

Oral hygiene instruction and periodontal maintenance

Group Type SHAM_COMPARATOR

Maintenance

Intervention Type PROCEDURE

Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy

Free gingival graft

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.

Group Type ACTIVE_COMPARATOR

Free gingival graft

Intervention Type PROCEDURE

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.

Maintenance

Intervention Type PROCEDURE

Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy

Collagen matrix

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.

Group Type ACTIVE_COMPARATOR

Collagen matrix

Intervention Type PROCEDURE

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.

Maintenance

Intervention Type PROCEDURE

Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy

Interventions

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Free gingival graft

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.

Intervention Type PROCEDURE

Collagen matrix

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.

Intervention Type PROCEDURE

Maintenance

Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Marco Clementini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimo De Sanctis

Role: STUDY_CHAIR

Università Vita-Salute San Raffaele

Locations

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Università Vita-Salute San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marco Clementini

Role: CONTACT

Phone: 0226432806

Email: [email protected]

Massimo De Sanctis

Role: CONTACT

Facility Contacts

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Marco Clementini

Role: primary

Other Identifiers

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Mucositis surgical

Identifier Type: -

Identifier Source: org_study_id