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

NCT06813846 | Recruiting DMC

• 1 other identifier: 23-035
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Papilla Reconstruction

Outcome Measures

Primary Outcomes (1)

• Pink Esthetic Score

  Pink esthetic score will be recorded for five variables: "mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site". A score of 2, 1, or 0 will be assigned to all five PES parameters. The two papillary scores (mesial and distal) will be assessed for the complete presence (score 2), incomplete presence (score 1) or absence (score0) of papillary tissue. The curvature of the facial soft tissue line, also defined as the line of emergence of the implant restoration from the soft tissues, will be evaluated as being identical (score 2 ), slightly different (score 1), or markedly different (score 0) compared to the natural control tooth and thus, provided a natural symmetrical or disharmonious appearance and in comparison to the contralateral tooth in terms of an identical vertical level (score 2), a slight (\<1 mm) discrepancy (score 1), or a major (\>1 mm) discrepancy

  6 Months

Secondary Outcomes (4)

• Healing Index

  1 Month

• Volumetric Changes

  baseline, 3, 6 and 9 months

• Visual analogue scale

  2 Weeks

• The Oral health impact profile (OHIP-14 questionnaire)

  6 Months

Study Arms (3)

"I" shaped incision

EXPERIMENTAL

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.

Procedure: "I" shaped incision

Split-Finger Procedure

EXPERIMENTAL

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.

Procedure: Split-Finger Procedure

Mid-Crestal Sulcular Incision

ACTIVE COMPARATOR

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.

Procedure: Mid-Crestal Sulcular Incision

Interventions

Mid-Crestal Sulcular Incision 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.

Mid-Crestal Sulcular Incision

Split-Finger Procedure 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.

Split-Finger Procedure

"I" shaped incision 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.

"I" shaped incision

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Acute infection
• Occlusal trauma
• Smokers
• Pregnancy and lactation
• Severe gag reflex

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

Faculty of Dentistry - The British University in Egypt

Cairo, Egypt

RECRUITING

Central Study Contacts

Sarah M. Rajab, Bachelor's Degree in Dentistry

CONTACT

+201148994336; sarah.rajab@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: July 12, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-12

Locations

EG (1)