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Evaluation Of Peri-Implant Emergence Profile Conditioned With Two Different Prosthetic Techniques

Evaluation Of Peri-Implant Emergence Profile Conditioned With Two Different Prosthetic Techniques (Randomized Controlled Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04329156
Enrollment
24
Registered
2020-04-01
Start date
2020-01-25
Completion date
2021-07-22
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

Brief summary

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

Detailed description

Twenty four patients having a non-restorable tooth will be rehabilitated with flapless immediate implant placement after tooth extraction. The emergence profile will be conditioned with either a stock or a customized healing abutment. A definitive screw retained restoration will be inserted 4 months postoperatively. Peri-implant tissues will be evaluated using pink and white esthetic score, radiographs and periodontal parameters at 3,6 and 12 months after implant placement.

Interventions

OTHERDigitally Flip Technique

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.

OTHERStock Healing Abutment

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.

Sponsors

Alexandria University
CollaboratorOTHER
Nourhan M.Aly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Pink esthetic score (PES)3 monthsThe 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.
White esthetic score (WES)6 monthsThe 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.
Peri-implant Probing Depth (PD)3 monthsPeri-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.
Modified Sulcus Bleeding Index (BI)3 monthsA 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.
Modified Plaque Index (PI)3 monthsThe 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.
Radiographic evaluation of alveolar bone using cone beat computed tomography (CBCT)3 monthsThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026