Assessment of Pink Esthetic Score After Using Two Papilla Reconstruction Exposure Techniques Versus Mid-Crestal Sulcular Incision in Second Stage Implant Surgery: a Randomized Controlled Clinical Trail

NCT ID: NCT06813846

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this randomized clinical trial is to assess the pink esthetic score with three different techniques in second-stage implant surgery.

Detailed Description

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Conditions

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Papilla Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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"I" shaped incision

A Labial horizontal incision with a #15c blade will be performed mesiodistally 0.5-1.0 mm inside from the labial border of the implant. A horizontal incision will also be performed, parallel to the buccal side, on the palatal side, which is in contact with the palatal border line of the implant different from the labial side. Another incision will be done bucco-lingually over the implant midline perpendicular to the horizontal incision lines performed on the labial and palatal sides. The flap will be reflected with care and the implant will be exposed to remove the cover screw. The healing abutment will be connected and both flaps will be folded up alongside the healing abutment intending them to heal without suture.

Group Type EXPERIMENTAL

"I" shaped incision

Intervention Type PROCEDURE

A Labial horizontal incision with a #15c blade will be performed mesiodistally 0.5-1.0 mm inside from the labial border of the implant. A horizontal incision will also be performed, parallel to the buccal side, on the palatal side, which is in contact with the palatal border line of the implant different from the labial side. Another incision will be done bucco-lingually over the implant midline perpendicular to the horizontal incision lines performed on the labial and palatal sides. The flap will be reflected with care and the implant will be exposed to remove the cover screw. The healing abutment will be connected and both flaps will be folded up alongside the healing abutment intending them to heal without suture.

Split-Finger Procedure

The surgical technique first designs 3 interlacing "fingers" over and adjacent to each implant site and will be extended around each adjacent tooth. · A sulcular incision will be made 2 to 3 mm to the palatal side from each tooth with a loop design (at least 2.0-2.5 mm) adjacent to the implant location. · The incisions will then be joined facially with a semicircular incision at the preplanned free tissue margin of the implant crown. · The facial "fingers" will be elevated to the desired interimplant height for the papillae. The middle "palatal finger" will then be split and reflected to the respective mesial and distal sides (each is at least 2.0-2.5 mm wide). · The soft tissue maintains its elevated position with a permucosal extension or a final prosthetic abutment that is extended through the soft tissue. · A modified vertical mattress suture will then be used to suture each papilla using 4-0 or 5-0 Gut or Vicryl sutures.

Group Type EXPERIMENTAL

Split-Finger Procedure

Intervention Type PROCEDURE

The surgical technique first designs 3 interlacing "fingers" over and adjacent to each implant site and will be extended around each adjacent tooth. · A sulcular incision will be made 2 to 3 mm to the palatal side from each tooth with a loop design (at least 2.0-2.5 mm) adjacent to the implant location. · The incisions will then be joined facially with a semicircular incision at the preplanned free tissue margin of the implant crown. · The facial "fingers" will be elevated to the desired interimplant height for the papillae. The middle "palatal finger" will then be split and reflected to the respective mesial and distal sides (each is at least 2.0-2.5 mm wide). · The soft tissue maintains its elevated position with a permucosal extension or a final prosthetic abutment that is extended through the soft tissue. · A modified vertical mattress suture will then be used to suture each papilla using 4-0 or 5-0 Gut or Vicryl sutures.

Mid-Crestal Sulcular Incision

A long incision over the crest and midway between buccolingual aspect through the gingiva from the site of the distal implant in mesial direction with intra-sulcular incisions in the teeth adjected to the implant site · Following a full or partial thickness flap is raised to establish access to cover screw.

Group Type ACTIVE_COMPARATOR

Mid-Crestal Sulcular Incision

Intervention Type PROCEDURE

A long incision over the crest and midway between buccolingual aspect through the gingiva from the site of the distal implant in mesial direction with intra-sulcular incisions in the teeth adjected to the implant site · Following a full or partial thickness flap is raised to establish access to cover screw.

Interventions

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Mid-Crestal Sulcular Incision

A long incision over the crest and midway between buccolingual aspect through the gingiva from the site of the distal implant in mesial direction with intra-sulcular incisions in the teeth adjected to the implant site · Following a full or partial thickness flap is raised to establish access to cover screw.

Intervention Type PROCEDURE

Split-Finger Procedure

The surgical technique first designs 3 interlacing "fingers" over and adjacent to each implant site and will be extended around each adjacent tooth. · A sulcular incision will be made 2 to 3 mm to the palatal side from each tooth with a loop design (at least 2.0-2.5 mm) adjacent to the implant location. · The incisions will then be joined facially with a semicircular incision at the preplanned free tissue margin of the implant crown. · The facial "fingers" will be elevated to the desired interimplant height for the papillae. The middle "palatal finger" will then be split and reflected to the respective mesial and distal sides (each is at least 2.0-2.5 mm wide). · The soft tissue maintains its elevated position with a permucosal extension or a final prosthetic abutment that is extended through the soft tissue. · A modified vertical mattress suture will then be used to suture each papilla using 4-0 or 5-0 Gut or Vicryl sutures.

Intervention Type PROCEDURE

"I" shaped incision

A Labial horizontal incision with a #15c blade will be performed mesiodistally 0.5-1.0 mm inside from the labial border of the implant. A horizontal incision will also be performed, parallel to the buccal side, on the palatal side, which is in contact with the palatal border line of the implant different from the labial side. Another incision will be done bucco-lingually over the implant midline perpendicular to the horizontal incision lines performed on the labial and palatal sides. The flap will be reflected with care and the implant will be exposed to remove the cover screw. The healing abutment will be connected and both flaps will be folded up alongside the healing abutment intending them to heal without suture.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients who already received implants in the anterior and premolar region
2. All implants were placed 4 months prior to uncovering in the mandible and 6 months prior to uncovering in the maxilla.
3. Patients with good oral hygiene
4. Medically free patients
5. Adequate keratinized tissue

Exclusion Criteria

1. Acute infection
2. Occlusal trauma
3. Smokers
4. Pregnancy and lactation
5. Severe gag reflex
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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Sarah Rajab

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry - The British University in Egypt

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sarah M. Rajab, Bachelor's Degree in Dentistry

Role: CONTACT

+201148994336

Facility Contacts

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Sarah M. Rajab, Bachelor's Degree in Dentistry

Role: primary

+201148994336

Other Identifiers

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23-035

Identifier Type: -

Identifier Source: org_study_id

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