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

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

Study Overview

• Status: Recruiting
• Conditions: Papilla Reconstruction
• Intervention / Treatment: Procedure: "I" shaped incision; Procedure: Split-Finger Procedure; Procedure: Mid-Crestal Sulcular Incision

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah M. Rajab, Bachelor's Degree in Dentistry; Phone Number: +201148994336; Email: Sarah.Rajab@bue.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry - The British University in Egypt
    • Contact: Sarah M. Rajab, Bachelor's Degree in Dentistry; Phone Number: +201148994336; Email: Sarah.Rajab@bue.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "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.	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.
Experimental: 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.	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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Index	The healing index included five clinical outcome parameters: tissue color (percent of red vs pink gingiva), presence of bleeding on palpation, presence of granulation tissue, incision margin (epithelization and connective tissue exposure), and presence of suppuration. The final score ranged from 0 (poor healing) to 5 (excellent healing).	1 Month
Volumetric Changes	To assess the volumetric differences between the baseline, 3, 6 and 9 months postoperatively. Digital replicas will be produced resembling various time intervals during treatment. Superimposing the different replicas of each case utilizing the best fit algorithm by using reference points from the tooth surfaces. The implant site region will be delineated by the mucogingival line, the mesial and distal papillary midline and the alveolar crest. Thus, alterations in volume between the digitized superimposed replicas could be recorded.	baseline, 3, 6 and 9 months
Visual analogue scale	Pain score is reported by the patient directly through The Visual Analogue Scale score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain)	2 Weeks
The Oral health impact profile (OHIP-14 questionnaire)	Will be used to assess limitation of function, pain, discomfort, social, psychological, physical disability, and general satisfaction. The OHIP-14 utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often). A lower score in any of the five categories indicates higher satisfaction.	6 Months

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 23-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No