Vertical Soft Tissue Augmentation With CTG vs ADM
ConditionImplant Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHarvard Medical School (HMS and HSDM)
About this trial
The study aims at comparing two different approaches for vertical soft tissue augmentation at implant sites exhibiting soft tissue dehiscences: autogenous connective tissue graft vs acellular dermal matrix + enamel matrix derivative
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Periodontally and systemically healthy
Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
Presence of single functional dental implant in the anterior with a PSTD
Disqualifiers
Contraindications for surgery
Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing
Patients pregnant or attempting to get pregnant (self-reported)
Untreated periodontitis
Trial design
Design model
Parallel
Treatments tested in this trial
Vertical soft tissue augmentation
Procedure/SurgeryVertical soft tissue augmentation with autogenous connective tissue graft (CTG)
Vertical soft tissue augmentation
Procedure/SurgeryVertical soft tissue augmentation with acellular dermal matrix (ADM) and enamel matrix derivative (EMD)
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Connective tissue graftActive comparator 1 intervention
Group B: Dermal matrix + EMDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Soft tissue dehiscence depth
Change of the depth of the Soft tissue dehiscence (vertical measurement of the complication, in relation to the level of the cemento-enamel junction of the contralateral homologous tooth) at 12 months compared to baseline (expressed in millimeters)
Time frame
12 monthsSecondary outcomes
1
Complete peri-implant soft tissue dehiscence (PSTD) coverage
Percentage of cases with complete resolution of the implant esthetic complication (expressed as a percentage)
Time frame
12 months2
mean peri-implant soft tissue dehiscence (PSTD) coverage
Percentage of coverage of the soft tissue dehiscence compared to baseline, measured with a formula considering final PSTD depth and initial PSTD depth (expressed as a percentage)
Time frame
12 months3
Mucosal thickness changes
Changes within the mucosal thickness measured with ultrasonography (expressed in mm)
Time frame
3, 6, and 12 months4
3D Volumetric changes
Changes within the buccal contour measured by superimposing digital impressions obtained with optical scanning (expressed in mm\^3)
Time frame
3, 6, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov