The plaque control record.
T J O'Leary, R B Drake, J E Naylor
https://pubmed.ncbi.nlm.nih.gov/4500182Actively Recruiting
Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID05537545
Randomized Trial on Timing of Soft Tissue Grafting After Immediate Implant Placement in the Front Upper Jaw
Led by University Ghent · Updated on 2023-10-03
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial involves patients who need a single immediate dental implant in the front upper jaw (premaxilla). Researchers are studying how the timing of soft tissue grafting affects healing and bone preservation around the implant. The study compares immediate soft tissue grafting done at the time of implant placement to delayed grafting performed three months later, aiming to find the best approach for implant success and tissue stability. Participants are randomly assigned to one of two groups: the immediate soft tissue grafting group or the delayed soft tissue grafting group. Both groups receive a connective tissue graft taken from the palate and inserted into the buccal mucosa to thicken the soft tissue around the implant. Along with implant placement, the bone socket is filled with a bone graft material to reduce bone loss and support soft tissue. Temporary crowns are placed within 48 hours, and sutures are removed one week after grafting. Throughout the study, patients undergo evaluations including low-dose cone beam CT scans at baseline, 1 year, and 5 years to measure bone resorption. Other assessments include soft tissue profile changes, esthetic scores, probing depths, plaque, and bleeding measurements. The study lasts several years to monitor long-term outcomes, ensuring detailed tracking of implant stability, tissue health, and esthetics.
CONDITIONS
Brief Title
Timing of Soft Tissue Grafting Following Immediate Implant Placement
Who Can Participate
Age: 20Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- At least 20 years old
- Good oral hygiene with full-mouth plaque score of 25% or less
- Presence of an incisor, canine, or premolar tooth in the upper jaw needing extraction
- At least 3 mm bone available at the front or palate side of the tooth socket for implant stability
- Intact buccal bone wall at time of extraction
- Written informed consent
You will not qualify if you...
- Pregnancy
- Systemic diseases
- Smoking
- Suppuration
- More than 1 mm gingival asymmetry between failing and opposite tooth
- Untreated periodontal disease
- Untreated dental cavities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implant Placement and Immediate Restoration
Duration - 1 day
Participants receive an immediate implant placement in the front upper jaw, with a temporary crown installed within 48 hours.
1 visit (in-person)
Immediate Soft Tissue Grafting or Delayed Soft Tissue Grafting
Duration - Immediate grafting group: procedure done at implant placement; Delayed grafting group: procedure done 3 months after implant placement.
Participants are assigned to either immediate soft tissue grafting at implant placement or delayed grafting 3 months later, where a connective tissue graft is harvested and inserted in the buccal mucosa.
1 visit for immediate grafting or 1 visit for delayed grafting
Suture Removal
Duration - 1 week after grafting
Sutures from the soft tissue grafting are removed approximately 1 week after the grafting procedure.
1 visit (in-person)
Follow-up Assessments
Duration - Up to 5 years
Participants are monitored for bone resorption, soft tissue changes, esthetic outcomes, and oral health over 1 to 5 years after treatment.
Trial Site Locations
Total: 1 location
1
Ghent University
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
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Research Team
J
Jan Cosyn, Professor
L
Lorenz Seyssens, Phd candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score.
Rudolf Fürhauser, Dionisie Florescu, Thomas Benesch...
https://pubmed.ncbi.nlm.nih.gov/16307569Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the esthetic zone of single immediate implants: A 1-year randomized controlled trial.
Elise G Zuiderveld, Wouter G van Nimwegen, Henny J A Meijer...
https://pubmed.ncbi.nlm.nih.gov/32918332A one-year prospective study on alveolar ridge preservation using collagen-enriched deproteinized bovine bone mineral and saddle connective tissue graft: A cone beam computed tomography analysis.
Lorenz Seyssens, Aryan Eghbali, Véronique Christiaens...
https://pubmed.ncbi.nlm.nih.gov/31456345The Mucosal Scarring Index: reliability of a new composite index for assessing scarring following oral surgery.
Retief Wessels, Sam De Roose, Thomas De Bruyckere...
https://pubmed.ncbi.nlm.nih.gov/29971512A Randomized Controlled Trial on the Timing of Soft Tissue Augmentation in Immediate Implant Placement: Soft Tissue Changes and Esthetic Outcome.
Thibault Struys, Véronique Christiaens, Thomas De Bruyckere...
https://pubmed.ncbi.nlm.nih.gov/39980395A Randomized Controlled Trial on the Timing of Soft-Tissue Augmentation in Immediate Implant Placement: Hard-Tissue Changes and Clinical Outcome.
Jan Cosyn, Thibault Struys, Pieter-Jan Van Hove...
https://pubmed.ncbi.nlm.nih.gov/39218777