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To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa

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ClinicalTrials.gov Identifier: NCT03338686
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ramzi V. Abou-Arraj, University of Alabama at Birmingham

Brief Summary:

This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa.

To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.


Condition or disease Intervention/treatment Phase
Dental Implants Alveolar Mucosa Procedure: Free Gingival Graft (FGG) Procedure: Connective Tissue Graft followed by Laser Gingivoplasty Not Applicable

Detailed Description:

Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants in question. While FGG is typically associated with higher postoperative discomfort than CTG, it has also been considered the gold standard in the treatment of these clinical conditions.

Specific aims for this project include the evaluation of:

  • KM width at 6 and 12 months following grafting with FGG and CTG
  • Change in tissue thickness of the grafted sites at 6 and 12 months
  • Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month
  • Patient centered outcomes including pain, bleeding, swelling and change in daily activities at 1 week for both groups and at 1 month for the CTG group

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial to Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
Actual Study Start Date : January 7, 2016
Actual Primary Completion Date : October 9, 2018
Estimated Study Completion Date : October 9, 2020

Arm Intervention/treatment
Active Comparator: Free Gingival Graft
Free Gingival Graft (FGG)
Procedure: Free Gingival Graft (FGG)
Free Gingival Graft (FGG) was performed on all study sites in this arm.
Other Name: palatal autogenous soft tissue graft

Experimental: Connective Tissue Graft followed by Laser Gingivoplasty
Connective Tissue Graft (CTG) followed by Laser Gingivoplasty
Procedure: Connective Tissue Graft followed by Laser Gingivoplasty
Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
Other Name: palatal autogenous subepithelial soft tissue graft




Primary Outcome Measures :
  1. The increase in keratinized mucosa (in mm) between the two grafts [ Time Frame: From baseline to 6 months ]
    Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 6 months following soft tissue grafting.

  2. The increase in keratinized mucosa (in mm) between the two grafts [ Time Frame: From baseline to 12 months ]
    Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting.


Secondary Outcome Measures :
  1. Measure the increase of KM width (in mm) as a result of laser gingivoplasty (GP) in the CTG group [ Time Frame: From baseline to 6 months ]
    Using a periodontal probe, KM width will be measured (in mm) at 6 months following laser gingivoplasty (GP) in the CTG group

  2. Measure the increase of KM width (in mm) as a result of laser gingivoplasty (GP) in the CTG group [ Time Frame: From baseline to 12 months ]
    Using a periodontal probe, KM width will be measured (in mm) at 6 months following laser gingivoplasty (GP) in the CTG group

  3. Measure changes in tissue thickness (in mm) between FGG and CTG [ Time Frame: From baseline to 6 months ]
    Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.

  4. Measure changes in tissue thickness (in mm) between FGG and CTG [ Time Frame: From baseline to 12 months ]
    Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.

  5. Assess esthetic outcomes [ Time Frame: From baseline to 6 months ]
    Assess esthetic outcomes using a newly developed peri-implant esthetic score (PIES)

  6. Assess esthetic outcomes [ Time Frame: From baseline to 12 months ]
    Assess esthetic outcomes using a newly developed peri-implant esthetic score (PIES)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. English speaking
  2. At least 18 years old
  3. Must be a patient of the UAB Dental School, able to read and understand informed consent document
  4. One or more adjacent dental implants having <2mm in width of keratinized mucosa or attached mucosa <1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type
  5. No crestal bone loss or minimal bone resorption not extending apical to first implant thread
  6. Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s)
  7. Implants requiring soft tissue grafting after placement (>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration

Exclusion Criteria:

  1. Non-English speaking
  2. Less than 18 years old
  3. Smokers/tobacco users (>10 cigarettes/day)
  4. Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  5. Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
  6. Presence of soft tissue recession exposing threads at implant site
  7. Presence of bony dehiscence at implant site (s)_ at time of surgery
  8. Previous soft tissue grafting at the implant site (s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338686


Locations
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United States, Alabama
University of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, United States, 35294-0007
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Ramzi V Abou-Arraj, DDS, MA University of Alabama at Birmingham
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Responsible Party: Ramzi V. Abou-Arraj, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03338686    
Other Study ID Numbers: STS-15
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramzi V. Abou-Arraj, University of Alabama at Birmingham:
Keratinized tissue
Keratinized mucosa
Attached mucosa
Dental implants
Free gingival graft
Connective tissue graft
Patient-centered outcomes