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The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis

Primary Purpose

Peri-Implantitis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Subepithelial connective tissue
Volume stable Collagen Matrix
No soft tissue augmentation
Sponsored by
Nadja Naenni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring tissue augmentation of moderate-severe peri-implantitis, implantoplasty, collagen matrix, autogenous connective tissue graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age > 18 years old (UZH, FRA) or > 21 years old (SIN), male and female.
  2. Diagnosed with periimplantitis of at least 1 implant in function for at least 1 year Diagnostic criteria

    • Presence of bleeding and/or suppuration on gentle probing.
    • Probing depths of ≥6 mm.
    • Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.
  3. Periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium)
  4. Good oral hygiene (full mouth plaque score <25%)
  5. Adequate control of inflammation (full mouth BOP <25%)
  6. Signed informed consent form

Exclusion Criteria:

  1. Pregnant or lactating female patient at inclusion
  2. Allergy or objection to porcine and bovine implantable biomaterials
  3. Allergy to Penicillin or NSAIDs
  4. Known or suspected non-compliance, drug or alcohol abuse
  5. Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant
  6. Smoking > 15 cigarettes a day
  7. Active periodontal disease

Sites / Locations

  • Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
  • National Dental Centre Singapore
  • Clinic of Reconstructive Dentistry, Center of Dental Medicine University of ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Subepithelial connective tissue group (SCTG)

Volume stable Collagen Matrix group (VCMX)

No soft tissue augmentation (GBR)

Arm Description

A SCTG will be harvested from the patient's palate with a dimension dependent on the size of the peri-implant osseous defect. The technique of harvesting a soft tissue grafting is well described and established in the literature. Following the administration of local anesthesia, the SCTG will be harvested using a single incision technique. The periosteum will be left intact. The thickness of the SCTG will be at least 1.5mm. A cross suture will be used to close the palatal incision. The SCTG will be placed on the buccal exposed implant threads (above the DBBM-C) exceeding 1mm in a coronal and apical direction, 3mm in a mesial and distal direction and then immobilized using a horizontal mattress connecting it to the lingual or palatal flap. The flaps are then closed primarily and tension-free following a horizontal periosteal releasing incision.

A VMCX (FibroGide®) will be hydrated in sterile saline, trimmed and adjusted to a dimension dependent on the size of the osseous peri-implant defect. The VCMX will then be placed as described above and then immobilized using a horizontal mattress connecting it to the lingual or palatal flap. The flaps are then closed primarily and tension-free following a horizontal periosteal releasing incision.

No barrier membranes will be placed. After filling the defect with the bone substitute, the flaps are closed primarily and tension-free following a horizontal periosteal releasing incision.

Outcomes

Primary Outcome Measures

Absence of bleeding/ suppuration on probing
A parameter for monitoring periodontal conditions
Increase in probing depth ≤ 1mm
A parameter for monitoring periodontal conditions
Absence of additional bone loss after therapy of more than 5mm from radiographic baseline
A parameter for monitoring periodontal conditions

Secondary Outcome Measures

Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Profilometric changes around the treated implant
The profilometric changes will be evaluated based on intra-oral scans
Early wound healing
The index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing receives a score of 5
Early wound healing
The index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing receives a score of 5
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Radiographic evaluation of the amount of hard tissue
evaluation of the marginal bone level changes
Oral Health Impact Profile-14
Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Oral Health Impact Profile-14
Patient's questionnaire - 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Oral Health Impact Profile-14
Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Oral Health Impact Profile-14
Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health

Full Information

First Posted
June 8, 2022
Last Updated
February 2, 2023
Sponsor
Nadja Naenni
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1. Study Identification

Unique Protocol Identification Number
NCT05415111
Brief Title
The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis
Official Title
The Adjunctive Effect of Soft Tissue Augmentation Procedures on the Surgical Treatment of Moderate-severe Peri-implantitis: A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
March 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nadja Naenni

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The key objective of the study is to compare the effects of soft tissue augmentation using a volume stable collagen matrix or autogenous connective tissue graft or no soft tissue augmentation in addition to bone grafting/implantoplasty in patients who undergo surgical therapy of peri-implantitis with respect to clinical resolution of the infection.
Detailed Description
The global burden of periimplantitis is expected to rise with the increasing popularity of dental implants as a replacement option. While many therapeutic interventions have been proposed, none have been proven superior. Surgical therapy is often indicated to gain access to the plaque infected implant threads and bone defects. Implantoplasty of suprabony defects have shown good results although adverse effects like soft tissue recession are common. Thin mucosa results in compromised outcomes following various surgical interventions around implants with increased recession and aesthetic failures. It has also been associated with increased marginal bone loss and severity of periimplantitis. Application of autogenous connective tissue grafts during surgical therapy of periimplantitis to increase the keratinised mucosa widths or attenuate post-implantoplasty recession showed promising results. No randomized controlled clinical trials investigating the effects of additional soft tissue augmentation with implantoplasty on periimplantitis lesions have been done so far. In addition, few have evaluated patient reported outcome measures, included non-European subjects and none reported on soft tissue alterations. The effect of soft tissue substitutes on surgical periimplantitis therapy remains unknown.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
tissue augmentation of moderate-severe peri-implantitis, implantoplasty, collagen matrix, autogenous connective tissue graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) or soft tissue substitute (VCMX) in addition to bone grafting of periimplantitis-affected implants. Study specific control intervention is the placement of a bone graft at periimplantitis-affected implants. No soft tissue grafts will be placed. The bone graft will remain permanently in the patients.
Masking
None (Open Label)
Masking Description
Masking is not possible for the intended interventions, as the harvest of the SCTG requires an additional surgical site at the palate, which will be recognized by the patient. The investigators will also be aware of the type of procedure, as both follow different operation procedures.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subepithelial connective tissue group (SCTG)
Arm Type
Active Comparator
Arm Description
A SCTG will be harvested from the patient's palate with a dimension dependent on the size of the peri-implant osseous defect. The technique of harvesting a soft tissue grafting is well described and established in the literature. Following the administration of local anesthesia, the SCTG will be harvested using a single incision technique. The periosteum will be left intact. The thickness of the SCTG will be at least 1.5mm. A cross suture will be used to close the palatal incision. The SCTG will be placed on the buccal exposed implant threads (above the DBBM-C) exceeding 1mm in a coronal and apical direction, 3mm in a mesial and distal direction and then immobilized using a horizontal mattress connecting it to the lingual or palatal flap. The flaps are then closed primarily and tension-free following a horizontal periosteal releasing incision.
Arm Title
Volume stable Collagen Matrix group (VCMX)
Arm Type
Active Comparator
Arm Description
A VMCX (FibroGide®) will be hydrated in sterile saline, trimmed and adjusted to a dimension dependent on the size of the osseous peri-implant defect. The VCMX will then be placed as described above and then immobilized using a horizontal mattress connecting it to the lingual or palatal flap. The flaps are then closed primarily and tension-free following a horizontal periosteal releasing incision.
Arm Title
No soft tissue augmentation (GBR)
Arm Type
Sham Comparator
Arm Description
No barrier membranes will be placed. After filling the defect with the bone substitute, the flaps are closed primarily and tension-free following a horizontal periosteal releasing incision.
Intervention Type
Procedure
Intervention Name(s)
Subepithelial connective tissue
Intervention Description
Study specific intervention is the placement of a soft tissue autogenous graft (SCTG) in addition to bone grafting of periimplantitis-affected implants.
Intervention Type
Procedure
Intervention Name(s)
Volume stable Collagen Matrix
Intervention Description
Study specific intervention is the placement of a soft tissue substitute (VCMX) in addition to bone grafting of periimplantitis-affected implants.
Intervention Type
Procedure
Intervention Name(s)
No soft tissue augmentation
Intervention Description
Study specific control intervention is the placement of a bone graft at periimplantitis-affected implants. No soft tissue grafts will be placed.
Primary Outcome Measure Information:
Title
Absence of bleeding/ suppuration on probing
Description
A parameter for monitoring periodontal conditions
Time Frame
6 months after surgery
Title
Increase in probing depth ≤ 1mm
Description
A parameter for monitoring periodontal conditions
Time Frame
6 months after surgery
Title
Absence of additional bone loss after therapy of more than 5mm from radiographic baseline
Description
A parameter for monitoring periodontal conditions
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Profilometric changes around the treated implant
Description
The profilometric changes will be evaluated based on intra-oral scans
Time Frame
6 months after surgery
Title
Profilometric changes around the treated implant
Description
The profilometric changes will be evaluated based on intra-oral scans
Time Frame
1 year after surgery
Title
Profilometric changes around the treated implant
Description
The profilometric changes will be evaluated based on intra-oral scans
Time Frame
3 year after surgery
Title
Profilometric changes around the treated implant
Description
The profilometric changes will be evaluated based on intra-oral scans
Time Frame
5 year after surgery
Title
Early wound healing
Description
The index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing receives a score of 5
Time Frame
1 month after surgery
Title
Early wound healing
Description
The index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing receives a score of 5
Time Frame
2 month after surgery
Title
Radiographic evaluation of the amount of hard tissue
Description
evaluation of the marginal bone level changes
Time Frame
6 months after surgery
Title
Radiographic evaluation of the amount of hard tissue
Description
evaluation of the marginal bone level changes
Time Frame
1 year after surgery
Title
Radiographic evaluation of the amount of hard tissue
Description
evaluation of the marginal bone level changes
Time Frame
3 years after surgery
Title
Radiographic evaluation of the amount of hard tissue
Description
evaluation of the marginal bone level changes
Time Frame
5 years after surgery
Title
Oral Health Impact Profile-14
Description
Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Time Frame
6 months after surgery
Title
Oral Health Impact Profile-14
Description
Patient's questionnaire - 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Time Frame
1 year after surgery
Title
Oral Health Impact Profile-14
Description
Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Time Frame
3 years after surgery
Title
Oral Health Impact Profile-14
Description
Patient's questionnaire - has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Time Frame
5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years old (UZH, FRA) or > 21 years old (SIN), male and female. Diagnosed with periimplantitis of at least 1 implant in function for at least 1 year Diagnostic criteria Presence of bleeding and/or suppuration on gentle probing. Probing depths of ≥6 mm. Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant. Periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium) Good oral hygiene (full mouth plaque score <25%) Adequate control of inflammation (full mouth BOP <25%) Signed informed consent form Exclusion Criteria: Pregnant or lactating female patient at inclusion Allergy or objection to porcine and bovine implantable biomaterials Allergy to Penicillin or NSAIDs Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant Smoking > 15 cigarettes a day Active periodontal disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jolanta Boruta
Phone
+41446343260
Email
jolanta.boruta@zzm.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Rasi, Dr.
Phone
+4144643365
Email
silvia.rasi@zzm.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadja Naenni, Dr.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Schwarz, Prof.
Facility Name
National Dental Centre Singapore
City
Singapore
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Zhen Lee, Dr.
Facility Name
Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadja Naenni, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis

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