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

Not Applicable

Recruiting

• Conditions: Peri-implant Mucositis

• Registration Number: NCT06645444
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-15
• Study Start: 2025-06-01
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gingival margin distance	Day 0 - month 3	The gingival margin distance will be measured from the highest gingival margin point in the buccal, palatal/lingual, mesial, and distal sides to the longitudinal implant line parallelly with the platform plane (buccal margin distance; BD, palatal/lingual margin distance; LD, mesial margin distance; MD and distal margin distance; DD).
Gingival margin height	Day 0 - month 3	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 3	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 3	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 Outcome Measures

Name	Time	Method
The Functional Implant Prosthodontics Score	Day 0 - month 3	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.

Trial Locations

Locations (1)

Marwa Helal; 🇪🇬 Cairo, Egypt