Peri-implant Mucositis
Conditions
Brief summary
: Immediate Implant Placement with different materials of customized healing abutment for guiding Peri-implant Soft Tissue Healing in Posterior Teeth: A Randomized controlled clinical trial.
Detailed description
This randomized clinical trial evaluates the effect of customized PEEK healing abutment versus composite healing abutment regarding Clinical evaluate 1. Gingival margin height 2. Gingival contour width 3. Gingival volume in BL & MD aspects on guiding the peri- implant soft tissue emergency profile in posterior teeth after immediate implant placement
Interventions
OTHERimmediate implant placement with customized PEEK healing abutment
* an intraoral examination will be done and a digital impression will be taken by the intraoral scanner (MEDIT i500) for a pre-extraction digital model, and CBCT will be taken for prosthetic-driven planning. * Once the treatment plan formulated, both STL (Standard Triangle Language) and DICOM (CBCT raw data) files format will be sent to produce the digital surgical guide with metal sleeve. * Then, a customized PEEK healing abutment will be made mimicking the anatomical cervical contour and pseudo-CEJ will be made by merging the STL and DICOM digitally and the exterior surface of the healing abutment will be designed to resemble a tooth. * Then, the technicians will mill the customized healing abutment digital design from a pre-milled 14 × 14 mm PEEK block (BioHPP, Bredent®, Bolzano, Italy) with a non-hex connection type, polished it, and sterilized it. * The digital surgical guide with a metal sleeve will be back for scheduled patient implant surgery.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria of participants: * Periodontally and systemic healthy patients * Patients aged \> 18 years * Non- restored teeth for many reasons (i.e. endodontic failure, unworthy for treatment in deep caries/non-caries lesion and root fracture), locate in the posterior area in the maxillary or mandibular arch indicate for customized implant with no need for additional bone and soft tissue augmentation procedures. * An adequate vertical bone for immediate implant placement. * Implants will be positioned with adequate primary stability so that transmucosal healing can be accomplished. * No taken medications known to interfere healing or periodontal tissue health or bone metabolism. * No previous periodontal surgery at involved sites. * Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
Exclusion criteria
* Patients with active periodontal diseases (bleeding on probing- probing depth \> 4 mm) or those under orthodontic treatment. * Poor oral hygiene (full mouth plaque score \> 25% and full mouth bleeding score \> 25%) * Smoking habits (\> 10 cigarettes/day) * Severe acute or chronic periodontitis * Severe bruxism habits * History of oral/IV bisphosphonates taking * Remote or recent radiation therapy in the oro-maxillo-facial area or recent chemotherapy. * Xerostomia * Pregnant and lactating mothers * Patients who have been received periodontal surgery in the study area during the last year. * Clinical or radiographic signs of periapical pathology contraindicating immediate implant placement. * Implants showing signs of peri-implant mucositis and peri-implantitis during the study period will be excluded from the following analyses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival margin height | Day 0 - month 12 | Gingival margin height will be measured from the highest gingival margin point in the buccal, lingual, mesial, and distal sides perpendicular to the platform plane (buccal height; BH, palatal/lingual height; LH, mesial height; MH and distal height; DH). |
| Gingival contour width | Day 0 - month 12 | The contour width will be measured from the outer sur face on the buccal and lingual sides to the implant center on the platform plane (buccal width; BW and palatal/lingual width; LW). |
| Gingival volume in BL & MD aspects | Day 0 - month 12 | Gingival volume will be measured on the gingiva above the platform plane for total gingival volume and separated with a mid-mesiodistal plane through the implant center for buccal and lingual gingival volume (total buccolingual volume; BLV, buccal volume; BV and lingual volume; LV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Implant Prosthodontics Score | Day 0 - month 12 | The Functional Implant Prosthodontics Score will be measured through five variables in order to limit bias: (1) interproximal contact and papillae, (2) occlusion static and dynamic, (3) design color and contour, (4) mucosa quality and quantity, and (5) bone x-ray. A scoring scheme of 0-1-2 resulting in a maximum score of ten (5X2) per implant reconstruction. |
Countries
Egypt
Outcome results
None listed