NCT04329156

Brief Summary

The aim of this study is to evaluate and compare two prosthetic conditioning techniques to create natural-like peri-implant emergence profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2021

Completed
Last Updated

December 4, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

March 28, 2020

Last Update Submit

December 1, 2023

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (17)

  • Pink esthetic score (PES)

    The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

    3 months

  • Pink esthetic score (PES)

    The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

    6 months

  • Pink esthetic score (PES)

    The PES is based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

    12 months

  • White esthetic score (WES)

    The WES is based on five variables of the clinical crown: general tooth form; outline and volume, color, surface texture, translucency and characterization. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

    6 months

  • White esthetic score (WES)

    The WES is based on five variables of the clinical crown: general tooth form; outline and volume, color, surface texture, translucency and characterization. Each variable will be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score.

    12 months

  • Peri-implant Probing Depth (PD)

    Peri-implant probing depth refers to the distance from the gingival margin to the bottom of the sulcus depth. The peri-implant sulcus depth will be measured using a graduated plastic autoclavable periodontal probe. In addition to the aforementioned intervals, it will be measured at the day of final restoration placement. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implants sulcus.Measurements will be made at 6 sites around each implant; mesio-buccal, mid-buccal, disto-buccal, mesio-palatal, mid-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on.

    3 months

  • Peri-implant Probing Depth (PD)

    Peri-implant probing depth refers to the distance from the gingival margin to the bottom of the sulcus depth. The peri-implant sulcus depth will be measured using a graduated plastic autoclavable periodontal probe. In addition to the aforementioned intervals, it will be measured at the day of final restoration placement. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implants sulcus.Measurements will be made at 6 sites around each implant; mesio-buccal, mid-buccal, disto-buccal, mesio-palatal, mid-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on.

    6 months

  • Peri-implant Probing Depth (PD)

    Peri-implant probing depth refers to the distance from the gingival margin to the bottom of the sulcus depth. The peri-implant sulcus depth will be measured using a graduated plastic autoclavable periodontal probe. In addition to the aforementioned intervals, it will be measured at the day of final restoration placement. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implants sulcus.Measurements will be made at 6 sites around each implant; mesio-buccal, mid-buccal, disto-buccal, mesio-palatal, mid-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on.

    12 months

  • Modified Sulcus Bleeding Index (BI)

    A score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding.

    3 months

  • Modified Sulcus Bleeding Index (BI)

    A score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding.

    6 months

  • Modified Sulcus Bleeding Index (BI)

    A score of 0-3 will be assigned to each labial and palatal surface of the implant then the average for each implant will be calculated according to the following criteria: Score 0: No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant. Score 1: Isolated bleeding spots visible. Score 2: Blood forms a confluent red line on margin. Score 3: Heavy or profuse bleeding.

    12 months

  • Modified Plaque Index (PI)

    The presence or absence of plaque around abutments will be scored at four sites of each implant; buccal, lingual, mesial and distal then the mean will be calculated. This will be carried-out by visual inspection with the aid of a mouth mirror and a plastic periodontal probe after air drying of the abutments. The criteria for assessment include: Score 0: No plaque in the gingival area, tested by running the side of plastic probe along the abutment surface at the entrance to the peri-implant sulcus. Score 1: Presence of a film of plaque near the gingival margin recognized by running the plastic periodontal probe along the abutment surface. Score 2: Moderate accumulation of plaque near or within the peri-implant sulcus, which could be seen naked eye. Score 3: Abundant plaque or soft matter within the peri-implant sulcus and or the mucosal sulcus margin and adjacent implant surface.

    3 months

  • Modified Plaque Index (PI)

    The presence or absence of plaque around abutments will be scored at four sites of each implant; buccal, lingual, mesial and distal then the mean will be calculated. This will be carried-out by visual inspection with the aid of a mouth mirror and a plastic periodontal probe after air drying of the abutments. The criteria for assessment include: Score 0: No plaque in the gingival area, tested by running the side of plastic probe along the abutment surface at the entrance to the peri-implant sulcus. Score 1: Presence of a film of plaque near the gingival margin recognized by running the plastic periodontal probe along the abutment surface. Score 2: Moderate accumulation of plaque near or within the peri-implant sulcus, which could be seen naked eye. Score 3: Abundant plaque or soft matter within the peri-implant sulcus and or the mucosal sulcus margin and adjacent implant surface.

    6 months

  • Modified Plaque Index (PI)

    The presence or absence of plaque around abutments will be scored at four sites of each implant; buccal, lingual, mesial and distal then the mean will be calculated. This will be carried-out by visual inspection with the aid of a mouth mirror and a plastic periodontal probe after air drying of the abutments. The criteria for assessment include: Score 0: No plaque in the gingival area, tested by running the side of plastic probe along the abutment surface at the entrance to the peri-implant sulcus. Score 1: Presence of a film of plaque near the gingival margin recognized by running the plastic periodontal probe along the abutment surface. Score 2: Moderate accumulation of plaque near or within the peri-implant sulcus, which could be seen naked eye. Score 3: Abundant plaque or soft matter within the peri-implant sulcus and or the mucosal sulcus margin and adjacent implant surface.

    12 months

  • Radiographic evaluation of alveolar bone using cone beat computed tomography (CBCT)

    The level of alveolar bone around each implant will be assessed using CBCT. The vertical bone change (distance from the implant platform to the first bone-to-implant contact, in mm) around each implant will be assessed at the buccal, lingual, mesial and distal aspects then the mean will be calculated.

    3 months

  • Radiographic evaluation of alveolar bone using cone beat computed tomography (CBCT)

    The level of alveolar bone around each implant will be assessed using CBCT. The vertical bone change (distance from the implant platform to the first bone-to-implant contact, in mm) around each implant will be assessed at the buccal, lingual, mesial and distal aspects then the mean will be calculated.

    6 months

  • Radiographic evaluation of alveolar bone using cone beat computed tomography (CBCT)

    The level of alveolar bone around each implant will be assessed using CBCT. The vertical bone change (distance from the implant platform to the first bone-to-implant contact, in mm) around each implant will be assessed at the buccal, lingual, mesial and distal aspects then the mean will be calculated.

    12 months

Study Arms (2)

Digitally Flip Technique

EXPERIMENTAL
Other: Digitally Flip Technique

Stock Healing Abutment

ACTIVE COMPARATOR
Other: Stock Healing Abutment

Interventions

Digitally Flip TechniqueOTHER

A prefabricated shell will be made then after implant placement, the shell will be attached to a plastic abutment using flowable composite to make a customized healing abutment.

Digitally Flip Technique
Stock Healing AbutmentOTHER

After implant placement, a stock healing abutment will be placed onto the implant and screwed on. It will be selected to be 1-2 mm above the gingival margin and slightly smaller in diameter than the intended final restoration.

Stock Healing Abutment

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of non-restorable maxillary anterior or premolar tooth and its healthy contra-lateral.
  • The gingival contour of the tooth to be extracted should be in harmony with the healthy contra-lateral tooth.
  • Having thick gingival biotype.

You may not qualify if:

  • Any medical disorder that could interfere with osseointegration or soft tissue healing.
  • Active oral infections or periodontal disease.
  • Presence of dehiscence or fenestration defects related to the tooth to be extracted.
  • Poor oral hygiene.
  • Heavy smokers (\>10 cigarette / day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Study Officials

  • Muhammed Badee, M.Sc

    Faculty of Dentistry, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR

  • Mohamed M Khamis, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY CHAIR

  • Ahmed A Abdelhakim, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY CHAIR

  • Rania Abdelaziz, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dental Public Health clinical instructor and study statistician

Study Record Dates

First Submitted

March 28, 2020

First Posted

April 1, 2020

Study Start

January 25, 2020

Primary Completion

May 1, 2021

Study Completion

July 22, 2021

Last Updated

December 4, 2023

Record last verified: 2023-12

Locations

EG(1)