Clinical trial NCT03425864: PES After Soft Tissue Augmentation Using CTG Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone
Official title: Pink Esthetic Score Evaluation After Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Augmentation
Keywords: immediate implant
connective tissue graft
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-02-08
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized using sequence generation program (Random.org in equal proportions between control group (immediate implant alone) and study group (immediate implant covered with sub-epithelial connective tissue graft with full coverage technique).
Primary purpose: TREATMENT

Brief summary: The goal of the present study is to compare the esthetic result and stability of gingival tissue over the immediate implant only and immediate implant with connective tissue in patients with single non-restorable tooth in the esthetic zone. The main null hypothesis to be tested is that the addition of SCTG to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.

Detailed description: Implant became a treatment modality for replacing missing or non-restorable teeth, providing clinical success rate and esthetic outcome. (1) In esthetic zone the main goal is not only the preservation of function but also the preservation of the esthetics. The esthetic outcome of implant supported restoration depend on the soft tissue volume and the soft tissue contour. (2) The placement of immediate implant after tooth extraction was proved as a very high success rate treatment modality. It provided several advantages such as reduction of the time between tooth extraction and the placement of prosthesis, reduction of the number of surgical treatments (3) and increase osteointegration between bone and implant surface (4).

Considering the survival rate of immediate implantation versus delayed implantation there is no significant difference with an overall success rate of 99.6%, it is just considered as a successful treatment modality, based on 802 implants (5).

On the other hand disadvantage related to esthetic outcome has been reported, showing facial gingival recession following the first year of function due to labial bone plate resorption. (6, 2).

A systematic review by Sanz et al.,(2012) compared the reduction of bone height and bone width between two groups the control group was delayed implant placement and the studied group was immediate implant placement and the mean difference between groups was of 13.11% (95% CI: from 3.83 to 22.4; P = 0.057) and 19.85% (95% CI: from 13.85 to 25.81)respectively, concluding that the early placement of dental implants after tooth extraction offers advantages in terms of soft and hard tissue preservation, compared with delayed implant placement , which affect the aesthetic (7 ) As a sequence of dimensional ridge alterations that occur following tooth extraction many studies reported a recession of marginal peri-implant mucosa, which affect the aesthetic outcome (8, 9, and 10).

A study made by Migliorati et al., (2015) between two groups, the control group (immediate loading implant treated without raising a flap) and the test group (immediate loaded implant treated with sub-epithelial connective tissue graft (SCTG) using the tunnel technique in the labial area) Both groups (47 implants) received deproteinized bovine bone minerals and implants were successfully integrated with a follow up period 2-year examination . Moreover the mean recession in the control group was 0.71mm (17.58%), one third of the control group reported recession \>1mm, and mean pink aesthetic score (PES) was 6.65, resulting in bad aesthetic. The test group showed an increase of the keratinized mucosa (KM) with a mean of 34.29% (0.5mm) and a mean recession of 0.2mm (10.01%), only one case (4%) showed recession \>1mm and the mean PES was 8. The thickening of soft tissue by the addition of SCTG, lead to compensation and maintenance of the loss of bone volume in the labial area (11).

The addition of sub epithelial connective tissue graft (SCTG) to the immediate implant was suggested for facial gingival biotype conversation. It was proved to be successful in preserving soft tissue levels. (12)

A systematic review was made to investigate if the addition of SCTG overcome the disadvantage of placement of immediate implant only or not, but unfortunately the included studies had different techniques and the number of the patients in those studies was few thus further RCT was necessary (13).

Eligibility criteria: Inclusion Criteria:

Non-restorable teeth located within the maxillary anterior area and premolars. Age ranged between 20 to 50 years old. Sufficient vertical inter-arch space upon centric occlusion. Patients with good oral hygiene. Intact labial/buccal bone plate.

10. a. Inclusion criteria

1. Age: 20-50. 2. Patients with single non-restorable teeth in anterior or premolar area. 3. "Patients with adequate bone volume for the dental implant procedure". 5. Patients who are compliant to oral hygiene measures. 6. Patient consent approval and signing.

10. b. Exclusion criteria:

1. Patients with any systemic disease that could affect normal healing of tissue and predictable outcome.
2. Patients with any habits that might affect osseointegration, such as heavy smoking and alcoholism.
3. Pregnant women.
4. Patients with untreated periodontal disease or the presence of pathologic condition at implant site.
5. Patients with Parafunctional habits that produce overload on the implant such as bruxism and clenching.
6. Shallow palate.

Primary outcomes:
measure: pink esthetic score
timeFrame: should be measured after 8 months below implant and graft placement
Secondary outcomes:
measure: tissue piotype
timeFrame: should be measured after 6 months below implant and graft placement
measure: width of keratinized gingiva
timeFrame: should be measured after 6 months below implant and graft placement
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Nada Abd El Aziz
state: Minia
Study officials:
References: