Clinical trial NCT06645444: Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 evaluation

1. Gingival margin distance
2. Gingival margin height
3. Gingival contour width
4. Gingival volume in BL \& MD aspects on guiding the peri- implant soft tissue emergency profile in posterior teeth after immediate implant placement

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival margin distance
timeFrame: Day 0 - month 3
measure: Gingival margin height
timeFrame: Day 0 - month 3
measure: Gingival contour width
timeFrame: Day 0 - month 3
measure: Gingival volume in BL & MD aspects
timeFrame: Day 0 - month 3
Secondary outcomes:
measure: The Functional Implant Prosthodontics Score
timeFrame: Day 0 - month 3
Other outcomes:
measure: Numerical rating scale
timeFrame: Day 0 - 2 hours- 24 hours
Locations:
city: Cairo
country: Egypt
facility: Marwa Helal
Study officials:
References: