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Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches with Immediate Implant Placement

Hard and Soft Tissue Alterations on the Use of Dual Zone Concept Versus Connective Tissue Graft At Flapless Maxillary Immediate Implant Placement. a 1-year Randomized Clinical Trial and Volumetric Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04310449
Enrollment
30
Registered
2020-03-17
Start date
2020-07-01
Completion date
2023-02-01
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Placement

Keywords

Immediate implant placement, Connective tissue graft, dual-zone therapeutic concept, customized healing abutment, buccal soft tissue contour, volumetric analysis

Brief summary

Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric difference of buccal soft tissue contour as well as the radiographic changes, following tooth extraction and immediate implant placement with dual zone concept versus connective tissue graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 15 patient in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized healing abutment. Patient allocation is random for the 2 groups. Data will be collected pre-surgically and at follow up periods (3,6,9&12 months and 6 months after delivery). Extra-oral scanning of the labial contour will be carried out to evaluate difference in contour gained and will be compared to the original contour and between treatment groups. Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.

Detailed description

After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. The allocation will be revealed to the principle investigator for the 3 implant groups after implant placement. Group 1: extraction will occur and then followed by immediate implant placement,using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (37). Particulate bone grafts are packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), Followed by customized healing abutment, the temporary cylindrical abutment twill be screwed to the implant and then flowable composite will be injected at the gingival margin level to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva, but will only seal the socket without extending deeper apically in the soft tissue. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque. Group 2: Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place, then will be covered by a customized healing abutment that will be done as mentioned before.

Interventions

PROCEDUREConnective tissue graft and customized healing abutment

Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant.

PROCEDUREDual zone concept and customized healing abutment

Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment.

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

• To compare the volumetric changes in the buccal soft tissue contour between immediate implants with CTG and customized healing abutments, and immediate implants with bone grafting in the dual zone and customized healing abutmnets

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth. 2. Adults at or above the age of 18. 3. Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue. 4. Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone. 5. Sagittal root position type 1 as described by Kan et al(30). 6. Good oral hygiene 7. Patient accepts to provide an informed consent.

Exclusion criteria

1. Smokers 2. Pregnant and lactating females. 3. Medically compromised patients. , as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31) 4. Patients with active infection related at the site of implant/bone graft placement. 5. Patients with untreated active periodontal diseases. 6. Patients with parafunctional habits

Design outcomes

Primary

MeasureTime frameDescription
Pink Esthetic Score (PES)6 months after delivery (18 months after IIP)The PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points. The grading using the PES suggested by Fürhauser will be performed. The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value (Fürhauser et al., 2005).

Secondary

MeasureTime frameDescription
Gingival thicknessBefore surgery - 6 months - 12 monthsMeasured with periodontal probe
Mid facial recession to assess the changes in tissue levelBefore surgery - 3 months - 6 months - 9 months - 12 monthsMeasured with 3D Viewer software
Interdental papillae height to assess changes in papilla heightBefore surgery - 3 months - 6 months - 9 months - 12 monthsMeasured with 3D Viewer software
Bucco-palatal widthBefore surgery - 12 monthsMeasured with CBCT
Modified Bleeding Index3 months - 6 months - 9 months - 12 monthsMeasured with Periodontal probe
Patient satisfaction12 monthsMeasured with Visual Analogue Scale (VAS). The patients will mark their satisfaction in a non-numerical 100 mm line ranging from not at all satisfied=0 (left) to very satisfied=100 (right), for each implant
Volumetric analysis of buccal contour to assess changes in buccal countourBefore surgery - 3 months - 6 months - 9 months - 12 monthsMeasured with Extra oral scanning + 3D viewer software
Modified Plaque Index3 months - 6 months - 9 months - 12 monthsMeasured with Periodontal probe

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026