## Protocol Section
### Identification Module
**NCT ID:** NCT06425770

**Brief Title:** Digital vs Conventional Impression in Capturing the Emergence Profile Around Maxillary Anterior Implant-supported Crowns

**Official Title:** Investigating the Accuracy of Conventional vs Digital Impressions and Conventional vs 3D Fabricated Casts in Capturing the Emergence Profile Around Maxillary Anterior Single Implant-supported Crowns

#### Organization Study ID Info
**ID:** 129/2023
#### Organization
**Class:** OTHER
**Full Name:** Semmelweis University
### Status Module
#### Completion Date
**Date:** 2026-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-10-05

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Semmelweis University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25).

**Detailed Description:** Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking.

Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype:

1. the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position
2. the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position
3. the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning

### Conditions Module

**Conditions:**

- Dental Implants, Single-Tooth

- Dental Impression Technique

**Keywords:**

- Peri-Implant Emergence Profile

- Dental Impression Technique

- Dental Implants, Single-Tooth

- Esthetics, Dental

- Crowns

- Denture, Partial, Fixed

- Computer-Aided Design

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created

**Intervention Names:**

- Procedure: conventional impresion and cast

**Label:** conventional cast

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration

**Intervention Names:**

- Procedure: indirect digital impression and 3D printed cast

**Label:** indirect digital impression and 3D printed cast

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration

**Intervention Names:**

- Procedure: direct digital impression

**Label:** direct digital impression

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- indirect digital impression and 3D printed cast

**Description:** the provisional restoration will be scanned with intraoral scanner extraorally, based on which a virtual model will be created, from which a 3D printed cast will be created with manually fabricated gingival mask based on the provisional restoration

**Name:** indirect digital impression and 3D printed cast

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- direct digital impression

**Description:** the emergence profile will be directly scanned with intraoral scanner at 0, 2, 10, and 20 minutes after removing the provisional restoration

**Name:** direct digital impression

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- conventional cast

**Description:** conventional impression with elastomer (silicon), from which a high-precision epoxi-resin cast with gingival mask will be created

**Name:** conventional impresion and cast

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** pink esthetic score of the definitive restoration

**Measure:** Pink esthetic score/PES

**Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up

**Description:** white esthetic score of the definitive restoration

**Measure:** White esthetic score/WES

**Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up

**Description:** functional implant prosthodontic score of the definitive restoration

**Measure:** functional implant prosthodontic score/FIPS

**Time Frame:** at impression taking, definitive prosthetic rehabilitation (2 weeks after impression), 6 and 12 months follow-up

#### Primary Outcomes

**Description:** The absolute mean deviation between the emergence profiles replicated with different impression techniques along the whole surface of the EP

**Measure:** 3D RMS - root mean square difference

**Time Frame:** at impression taking, 0,2,10,20 mins

#### Secondary Outcomes

**Description:** Vertical height change of the buccal gingiva marginal level measured at the mesial and distal papilae and mid-facial levels

**Measure:** Linear vertical soft tissue change

**Time Frame:** at impression taking, 0,2,10,20 mins

**Description:** Horizontal thickness change of the buccal and palatal gingiva at three levels at each third of the distance between the implant platform and the marginal gingiva.

**Measure:** Linear horizontal soft tissue change

**Time Frame:** at impression taking, 0,2,10,20 mins

**Description:** The absolute mean deviation between the emergence profiles replicated with different impression techniques along vertical and horizontal cross-sections.

**Measure:** 2D RMS - root mean square difference

**Time Frame:** at impression taking, 0,2,10,20 mins

**Description:** Patient evaluation of the different types of impression methods on a visual analoge scale based questionnaire

**Measure:** Patient reported outome measures - evaluation of the impression method

**Time Frame:** at the end of each session of the digital and conventional impression taking

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult above 18 yo
* No systematic deseases
* Good oral hygene (FMPS \< 25%)
* Stable occlusion
* Thick phenotype
* Single missing maxilary anterior (FDI #15-25 position) tooth replaced with osseointegrated bone level impant
* Correctly formed soft tissue with CAD/CAM temporary abutment for min. 3 months
* Neighbouring teeth in place and in good condition
* Patient voluntarily accepts and signs the patient leaflets for the trial

Exclusion Criteria:

* Active periodontitis
* Peri-implant inflammation

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mikulas.krisztina1@semmelweis.hu

**Name:** Krisztina Mikulás, PhD

**Phone:** +3614591500

**Phone Ext:** 59115

**Role:** CONTACT

**Contact 2:**

**Email:** qian.xinyi@semmelweis.hu

**Name:** Xinyi Qian

**Phone:** +3614591500

**Phone Ext:** 59313

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Budapest

**Contacts:**

***Contact 1:***

- **Email:** mikulas.krisztina1@semmelweis.hu

- **Name:** Krisztina Mikulás, PhD

- **Phone:** 3614591500

- **Phone Ext:** 59115

- **Role:** CONTACT

***Contact 2:***

- **Email:** qian.xinyi@semmelweis.hu

- **Name:** Xinyi Qian

- **Phone:** 3614591500

- **Phone Ext:** 59313

- **Role:** CONTACT

**Country:** Hungary

**Facility:** Semmelweis University, Department of Prosthodontics

**State:** Pest

**Status:** RECRUITING

**Zip:** 1088

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Prosthodontics, Semmelweis University

**Name:** Krisztina Mikulás, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Li J, Chen Z, Wang M, Wang HL, Yu H. Dynamic changes of peri-implant soft tissue after interim restoration removal during a digital intraoral scan. J Prosthet Dent. 2019 Sep;122(3):288-294. doi: 10.1016/j.prosdent.2018.07.020. Epub 2019 Mar 15.

**PMID:** 30885583

**Citation:** Xiong J, Sun W, Huang B, Ji W, Shi B. Effect of the implant-supported provisional restoration on the accuracy of digital peri-implant mucosa replication-A clinical study. Clin Oral Implants Res. 2022 Jun;33(6):598-606. doi: 10.1111/clr.13921. Epub 2022 Mar 26.

**PMID:** 35290685

**Citation:** Monaco C, Scheda L, Baldissara P, Zucchelli G. Implant Digital Impression in the Esthetic Area. J Prosthodont. 2019 Jun;28(5):536-540. doi: 10.1111/jopr.12991. Epub 2018 Dec 3.

**PMID:** 30357992

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000015853

- Term: Cysteine Proteinase Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M15630

- Name: Silicon

- Relevance: LOW

- As Found: Unknown

- ID: M40889

- Name: Calpastatin

- Relevance: HIGH

- As Found: Electric

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T4

- Name: Cysteine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000033668

- Term: Calpastatin

### Misc Info Module

- Version Holder: 2024-05-31
