Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Esthetic Outcomes and Digital Soft Tissue Assessment of Customized Versus Stock Healing Abutments for Immediate Implants in the Maxillary Esthetic Zone: A Pilot Randomized Controlled Trial
The aim of this study is to compare customized and stock healing abutments for peri-implant soft tissue changes after immediate implant placement in the maxillary esthetic zone, and to assess the feasibility of a full-scale trial.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Preservation of the peri-implant soft tissue contour and papillae after immediate implant placement is essential for a predictable esthetic result. If customized healing abutments provide better soft tissue outcomes than stock abutments, they could be recommended as a routine step in immediate implant placement in the esthetic zone. Because high-quality comparative evidence is lacking, the present pilot randomized trial was designed to compare the peri-implant soft tissue changes (Pink Esthetic Score at 6 months) around customized versus stock healing abutments, and to provide the feasibility data (recruitment, retention, variability of outcomes) needed to calculate the sample size of a full-scale trial.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Good general health (ASA I or II).
- Adult patients above 18 years of age.
- Males or females.
- Good oral hygiene and compliance with follow-up visits.
- Willing to sign the informed consent.
- Non-restorable (hopeless) tooth in the maxillary esthetic zone (canine to canine).
- Intact facial bone wall of the socket after extraction.
- Sufficient bone apical and palatal to the socket to achieve primary implant stability (≥ 35 Ncm).
- Presence of adjacent and opposing natural teeth.
- Healthy periodontium around adjacent teeth.
Exclusion Criteria:
- Participants with uncontrolled systemic illness.
- Pregnant or lactating females.
- Smokers.
- Concomitant participation in another study.
- Heavy bruxism habits.
- History of radiotherapy to the head and neck region or bisphosphonate therapy.
- Patients who refuse to participate.
- Acute infection or abscess at the site.
- Facial bone wall dehiscence or defect.
- Insufficient bone for primary stability.
- Active periodontal disease.
- Previous bone augmentation or implant at the same site.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Immediate implant placement with a customized healing abutment
A customized healing abutment replicating the emergence profile of the extracted tooth will be fabricated chairside using resin composite on a titanium abutment / digitally designed and milled and connected to the implant at the same surgical visit. Its design will be based on the cervical cross-section of the extracted tooth. |
Immediate implant placement with a customized healing abutment |
|
Aktiv komparator: Immediate implant placement with a prefabricated (stock) healing abutment.
• A prefabricated healing abutment will be selected and connected to the implant at the same surgical visit, with the screw torqued according to the manufacturer's instructions. |
Immediate implant placement with a prefabricated (stock) healing abutment. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pink Esthetic Score (PES)
Tidsram: 6 months
|
PES criteria scoring (0-14) |
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Extended Pink Esthetic Score (E-PES)
Tidsram: 6 months
|
E-PES criteria Scoring (0-18) |
6 months
|
|
Probing depth (PD)
Tidsram: 6 months
|
by peridontal probe in millimeters |
6 months
|
|
Buccal soft tissue contour
Tidsram: 6 months
|
Intraoral scan / stone cast superimposition in millimeters |
6 months
|
|
Keratinized mucosa width (KMW)
Tidsram: 6 months
|
Periodontal probe |
6 months
|
|
Marginal bone level (MBL)
Tidsram: 6 months
|
CBCT / periapical radiograph |
6 months
|
|
Digital Assesment of Buccal Mucosa
Tidsram: 6 months
|
digital scanner |
6 months
|
|
Patient Satisfaction for Esthetics
Tidsram: 6 months
|
binary questionnaire (yes/No) |
6 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-2026
Läkemedels- och apparatinformation, studiedokument
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