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Completed

NCT Number: NCT05273476

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

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.

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Key information

Conditions

Inadequately Attached Gingiva

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged >=18 years and periodontally and systemically healthy;
  • 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);
  • Need of keratinized tissue augmentation for aesthetic purpose and/or functional reasons;
  • Full mouth probing depths <=5mm;
  • Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <=15%;
  • Be able to comply with all procedures related to the study.

Exclusion criteria

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

Treatment and study plan

apically repositioned flap+ xenogeneic collagen matrix +free gingival graft

Procedure

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

Primary outcomes

  1. change from baseline keratinized mucosa width at 2 and 6 months

    Time frame: baseline, at 2,6 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)

Secondary outcomes

  1. change from baseline keratinized mucosa thickness at 2 and 6 months

    Time frame: baseline, at 2,6 months

    measured at the middle point of an apical-coronal direction at the mid-buccal aspect using an endodontic file with a rubber stop

  2. change from baseline Gingival index at 2 and 6 months

    Time frame: baseline, at 2,6 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.

  3. change from baseline probing depth at 2 and 6 months

    Time frame: baseline, at 2,6 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)

  4. Post-operative pain

    Time frame: at 1 week after surgery

    evaluated using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)

  5. change from 2 months patient satisfaction at 6 months

    Time frame: at 2 and 6 months post operation

    using a visual analog scale (VAS) ranging from 0 to 10 (0 = extremely dissatisfied and 10 = extremely satisfied)

  6. dosage of postoperative analgesic drugs

    Time frame: at 1 week after surgery

    dosage of postoperative analgesic drugs that patients take after surgery

  7. operation time

    Time frame: during the surgery

    measured from the start of the first incision to the end of the last suture

  8. esthetic score

    Time frame: at 6 months post operation

    assessed by judging on the colour, contour, and texture of the surgical sites

  9. change from baseline depth of recession at 2 and 6 months

    Time frame: baseline, at 2,6 months

    The distance from the implant margin to the gingival margin was measured with a periodontal probe

  10. change from baseline width of recession at 2 and 6 months

    Time frame: baseline, at 2,6 months

    The proximal and distal level of soft tissue retraction at the top of implant was measured by periodontal probe

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2022
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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