Using different materials for healing abutments in dental implants

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

This study is testing whether customized healing abutments made from a special plastic or from composite materials help the soft tissue heal better around dental implants placed right after tooth removal.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Cairo University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Cairo)
• Trial ID: NCT06645444 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of customized healing abutments made from PEEK compared to composite materials on the healing of soft tissue around dental implants placed immediately in the posterior teeth. It focuses on various clinical evaluations, including gingival margin distance, height, contour width, and volume. The study aims to determine which material better guides the peri-implant soft tissue healing process. Participants will be randomly assigned to receive either type of healing abutment following immediate implant placement.

Who should consider this trial

Good fit: Ideal candidates are healthy adults over 18 years old with non-restored posterior teeth suitable for immediate implant placement.

Not a fit: Patients with active periodontal diseases or those requiring additional bone and soft tissue augmentation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the healing outcomes of dental implants, leading to better aesthetic and functional results for patients.

How similar studies have performed: While there have been studies on healing abutments, this specific comparison of PEEK and composite materials in immediate implant placement is relatively novel.

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.

Where this trial is running

Cairo

• Marwa Helal — Cairo, Egypt (RECRUITING)

Study contacts

• Study coordinator: Marwa Helal

Conditions: Peri-implant Mucositis