Augmentation of Keratinized Tissue Around Dental Implant With a Xenogeneic Collagen Matrix and the Free Gingival Graft

Augmentation of Keratinized Tissue Around Dental Implant With Combined Application of a Xenogeneic Collagen Matrix and the Free Gingival Graft : a Single Arm Clinical Trial

The purpose of this study is to compare the clinical effects of combined application of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft.

Study Overview

• Status: Completed
• Conditions: Inadequately Attached Gingiva
• Intervention / Treatment: Procedure: apically repositioned flap+ xenogeneic collagen matrix +free gingival graft

Detailed Description

The purpose of this study is to compare the clinical effects of combined application of a xenogeneic collagen matrix and the free gingival graft in augmentation of keratinized tissue around dental implant by single arm clinical trial, compared with historical control group 1:application of a xenogeneic collagen matrix,and historical control group 2:application of the free gingival graft. This study designed a single arm clinical trial. The included patients will all be treated with apical repositioned flap with a xenogeneic collagen matrix and the free gingival graft. The width of keratinized mucosa, thickness of keratinized mucosa, gingival index, probing depth will be measured before surgery and at 2, 6 months postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged >=18 years and periodontally and systemically healthy;
2. Presence of at least one site with <=2 mm of keratinized tissue; associated with a shallow vestibule in the edentulous region after implant surgery (no more than three consecutive implants);
3. Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
4. Full mouth probing depths <=5mm;
5. Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <=15%;
6. Be able to comply with all procedures related to the study.

Exclusion Criteria:

1. Smoking;
2. Pregnant or lactating women;
3. Untreated periodontal disease;
4. Presence of systemic disorders (diabetes, heart disease, tumor or any other condition that could contraindicate periodontal surgery);
5. Use of medications (immunosuppressants, phenytoin, or anything else that might affect mucosal healing and repair);
6. Under radiotherapy;
7. Allergy to the collagen;
8. Previous mucogingival surgery in the area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: strip; apically repositioned flap+ xenogeneic collagen matrix +free gingival graft	Procedure: apically repositioned flap+ xenogeneic collagen matrix +free gingival graft; Harvest a strip free gingival graft from the palate, then place it above apically repositioned flap and fix xenogeneic collagen matrix to the recipient bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline keratinized mucosa width at 2 and 6 months	measured from the mucogingival junction to the mucosa margin or the zenith of alveolar ridge at the mid-buccal aspect of each implant using a periodontal probe (UNC15)	baseline, at 2,6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline keratinized mucosa thickness at 2 and 6 months	measured at the middle point of an apical-coronal direction at the mid-buccal aspect using an endodontic file with a rubber stop	baseline, at 2,6 months
change from baseline Gingival index at 2 and 6 months	assessed at four gingival sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, and palatal/lingual) . Indicated by numbers, 0: normal gingiva; 1: slightly edematous gingiva that does not bleed on probing; 2: edematous gingiva that bleeds on probing; 3: gingiva that has a tendency to bleed spontaneously or ulcerate.	baseline, at 2,6 months
change from baseline probing depth at 2 and 6 months	measured at six sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, mesio-palatal/lingual, mid-palatal/lingual, and disto-palatal/lingual) using a periodontal probe (UNC15)	baseline, at 2,6 months
Post-operative pain	evaluated using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)	at 1 week after surgery
change from 2 months patient satisfaction at 6 months	using a visual analog scale (VAS) ranging from 0 to 10 (0 = extremely dissatisfied and 10 = extremely satisfied)	at 2 and 6 months post operation
dosage of postoperative analgesic drugs	dosage of postoperative analgesic drugs that patients take after surgery	at 1 week after surgery
operation time	measured from the start of the first incision to the end of the last suture	during the surgery
esthetic score	assessed by judging on the colour, contour, and texture of the surgical sites	at 6 months post operation
change from baseline depth of recession at 2 and 6 months	The distance from the implant margin to the gingival margin was measured with a periodontal probe	baseline, at 2,6 months
change from baseline width of recession at 2 and 6 months	The proximal and distal level of soft tissue retraction at the top of implant was measured by periodontal probe	baseline, at 2,6 months

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Peihui Ding, Doctor, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 5, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DHZhejiangU-2022（023）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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