Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments

Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments Using a CAD/CAM Technique: Randomized Controlled Clinical Trial

The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal; Dental Implant; Immediate Dental Implant
• Intervention / Treatment: Device: Standard healing abutment; Device: Individualized healing abutment

Detailed Description

Objective: To check if custom healing abutments manufactured using CAD/CAM technique in immediate implants promote greater dimensional stability of the peri-implant tissue compared to standard healing abutments.

Methods: After the extraction, an immediate Klockner Vega+ implant will be placed and the gap will be filled with a bone substitute (Cerabone, Botiss). The patient will then be randomized to the control group (standard healing abutment) or the test group (custom healing abutment using CAD/CAM technique). In the latter case, a peripheral seal is achieved, allowing for wound closure and stabilization of the clot with the same shape as the crown in its transmucosal part.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javi Vilarrasa, MSc; Phone Number: +34 628553000; Email: jvilarrasa@uic.es
• Study Contact Backup: Name: Nicolas Padros, DDs; Phone Number: +34 628289185; Email: nico.padros@uic.es

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Contact: Javi Vilarrasa, Mr; Email: jvilarrasa@uic.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult patient ( 25 years old).
• Need for extraction of an irrational tooth to be treated in the molar/premolar position of the upper/lower arch.
• Presence of 2mm of keratinized gingiva.
• Bone dehiscence in the alveolar walls of 2 mm. 2 mm.
• Adequate amount of bone in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm at the base of the septum).
• Plaque index (FMSPI, full mouth score plaque index) < 10%.
• Non-smokers or smokers of less than 10 cigarettes per day.
• Absence of systemic diseases that contraindicate implant surgery.

Exclusion Criteria:

• Presence of alveoli with dehiscence >2mm.
• Presence of adjacent implants.
• < 2mm of keratinized gingiva.
• Presence of active infection (fistula, suppuration) at the extraction site.
• Presence of apical granuloma >2mm in diameter in the root(s) of the tooth or teeth to be extracted.
• Residual bone apical to the extraction insufficient to anchor the implant.
• Pregnant or lactating women.
• Severe cognitive or psychiatric disorders.
• Compromised general health status ( ASA IV).
• Use of drugs that alter bone metabolism and healing.
• Absence of manual primary stability of the implant
• Bone dehiscence or fenestration after implant placement (manual rotation).
• Gap 2mm between the implant and the vestibular bone wall.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Will receive standard healing abutments	Device: Standard healing abutment; Participants will undergo a surgery to place an immediate klockner dental implant and will be receive a standard healing abutment
Experimental: Individualized healing abutment group; Will receive individualized healing abutments	Device: Individualized healing abutment; Participants will undergo a surgery to place an immediate klockner dental implant and will be receive an individualized healing abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Buccal-lingual/palatal soft tissue dimensional changes	They will be evaluated after superimposing the initial STL files with the follow-up ones. In addition, photos, periapical radiographs and a new intraoral scan at 3 months, 6 months and 1 year will be taken. In a 2D buccal-lingual slice corresponding to the center of the ridge, measure at the vestibular and palatal level from the point of maximum preoperative STL soft tissue contour (mucosal margin and at 3 mm and 5 mm apical to the margin).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dehiscence of peri-implant vestibular and lingual/palatal mucosa:	Dehiscence can be assessed by carefully examining the peri- implant mucosa for any signs of tissue separation or exposure. This can be done visually during clinical examination.	12 months
Vestibulo-lingual/palatal dimensional changes of the alveolar bone (CBCT)	To measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions. measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions.	12 months
Horizontal remodeling of vestibular and lingual/palatal cortex (CBCT)	CBCT scans can also be used to assess horizontal remodeling of the cortical bone. Analyze the CBCT images to measure changes in cortical thickness or contour.	12 months
Thickness of vestibular and lingual/palatal cortex (CBCT)	CBCT scans can provide measurements of cortical thickness in the vestibular and lingual/palatal regions of the alveolar bone.	12 months
Vertical changes of the vestibular and lingual/palatine cortex (CBCT)	Use CBCT scans to measure any vertical changes in the vestibular and lingual/palatal cortical bone regions.	12 months
Marginal bone level (periapical x-ray)	Periapical X-rays are commonly used to assess marginal bone levels around dental implants. Measure the distance from the implant-abutment interface to the crestal bone on these radiographs.	12 months
Probing pocket depth	Probing pocket depth can be measured using periodontal probes. Insert the probe gently into the peri-implant sulcus and measure the distance from the mucosal margin to the implant-abutment interface.	12 months
Bleeding/Suppuration on probing	Assess bleeding or suppuration during probing. Note if there is any bleeding or exudate from the peri-implant sulcus when probing the tissues.	12 months
Implant survival	Implant survival can be determined by assessing whether the implant remains in place and functional over the study period. Any implant removals or failures should be documented.	12 months
Patient-reported variables (satisfaction, pain)	Subjective assessment of pain intensity and patient satisfaction using a 10-cm visual analog scale. The extremes of the scale are the extreme expressions of pain and discomfort (i.e., no pain and the worst imaginable pain); Type of variable (units): scale (mm).; Time of registration: Appointment 4 (surgery), Appointment 5 (follow-up), Appointment 10 (End of study)	12 months

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Investigators: Principal Investigator: Matteo Albertini, PhD, Universidad Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: implant; soft tissue
• Other Study ID Numbers: PER-ECL-2023-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No