Surgical Protocol for Prevention of Mucositis

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.

Study Overview

• Status: Unknown
• Conditions: Mucositis
• Intervention / Treatment: Procedure: Maintenance; Procedure: Free gingival graft; Procedure: Collagen matrix

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 Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20100
    • Recruiting
    • Università Vita-Salute San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Maintenance; Oral hygiene instruction and periodontal maintenance	Procedure: Maintenance; Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy
Active Comparator: 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.	Procedure: Maintenance; Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy; Procedure: 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.
Active Comparator: 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.	Procedure: Maintenance; Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	3, 6 and 12 months after treatment
marginal bone loss (MBL)	marginal bone loss at mesial and distal aspect, measured on periapical X-ray	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).	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.	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).	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	6 and 12 months after treatment

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Mucositis; Free gingival graft; CTG; Surgical Treatment; Keratinised tissue; Collagen matrix
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: Mucositis surgical

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No