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NCT Number: NCT06645444

Immediate Implant Placement With Different Materials of Customized Healing Abutment for Guiding Peri-implant Soft Tissue Healing in Posterior Teeth

: 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.

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Key information

Conditions

Peri-implant Mucositis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Helal

Cairo, 02, Egypt

About this study

This randomized clinical trial evaluates the effect of customized PEEK healing abutment versus composite healing abutment regarding Clinical evaluate

  • Gingival margin height
  • Gingival contour width
  • Gingival volume in BL & MD aspects on guiding the peri- implant soft tissue emergency profile in posterior teeth after immediate implant placement

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

immediate implant placement with customized PEEK healing abutment

Other
  • 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.

Primary outcomes

  1. Gingival margin height

    Time frame: 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).

  2. Gingival contour width

    Time frame: 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).

  3. Gingival volume in BL & MD aspects

    Time frame: 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 outcomes

  1. The Functional Implant Prosthodontics Score

    Time frame: 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.

Other outcomes

  1. Numerical rating scale

    Time frame: Day 0 - 2 hours- 24 hours

    is a psychometric response to pain scale which will be used in questionnaires through asking the patients about the occurrence of discomfort and postoperative pain Will be evaluated by questionnaire to assess perceived pain following crown insertion

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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