Clinical trial NCT02864862: Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
Official title: Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Implant
Immediate Dental Implant
Soft Tissue Augmentation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone.


Eligibility criteria: Inclusion Criteria:

* patients who are in need of a tooth extraction at the maxillary premolar, canine and incisor region, and subsequent single implant placement.
* The reasons for extraction will include poor endodontic prognosis and/or unrestorable teeth (extensive caries, traumatic fractures, fractures of endodontically treated teeth, root perforation, root resorption with or without radiographic periapical lesion up to 3 mm in diameter). patients who are systemically healthy or with controlled common systemic conditions (controlled hypertension, controlled diabetes HbA1c up to 7 %).
* adjacent teeth have to be present and the eligible tooth has esthetically acceptable buccal gingival margin position prior to surgery, compared to neighboring teeth and contralateral tooth, and adequate width of buccal keratinized gingiva(≥3mm).
* level of radiographic bone level has the distance from CEJ to interproximal crest up to 4 mm.
* Location of buccal alveolar crest has to be generally within 4 mm from the free gingival margin, verified after the extraction, before randomization; and fenestration, if present, up to 3mm in diameter at the apical part of the root and affecting less than 30% of the buccal socket wall.

Exclusion Criteria:

* currently smoke exceeding 10 cigarettes/ day
* severe parafunctional habits, malocclusion or intent of orthodontic therapy in the future and are pregnant.
* teeth in the surgical site will be excluded if there is advanced periodontal disease or periapical lesion causing significant bony defects that are beyond the criteria mentioned at Section 3.3.
* allergy to antibiotics contained in the ADM (Gentimicin, Cefoxitin, Lincomcin, polymixin B and Vancomycin) will not be included in the immediate implant combined with ADM group.

Primary outcomes:
measure: Change in Ridge Dimension
timeFrame: baseline, 6 months after surgery
measure: Change in Ridge Dimension
timeFrame: baseline, 12 months after surgery
Secondary outcomes:
measure: Change in Gingival Level
timeFrame: baseline, 6 months after surgery
measure: Change in Gingival Thickness
timeFrame: baseline, 6 months after surgery
measure: Change in Width of Keratinized Gingiva
timeFrame: baseline, 6 months after surgery
measure: Change in Alveolar Bone Level (Marginal)
timeFrame: baseline, 6 months after surgery
measure: Change in Alveolar Bone Level (Crestal)
timeFrame: baseline, 6 months after surgery
measure: Change in Bone Dimension
timeFrame: baseline, 6 months after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Chun-Teh Lee, DDS, DMSc
role: PRINCIPAL_INVESTIGATOR
References: