Actively Recruiting

Phase Not Applicable
All Genders
ID06813846

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 Trial

Led by British University In Egypt · Updated on 2025-02-12

33

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pink esthetic score using three different techniques during second-stage implant surgery. This randomized clinical trial aims to compare the outcomes of two papilla reconstruction exposure methods against the mid-crestal sulcular incision. The study focuses on patients who have received dental implants in the anterior and premolar regions, assessing esthetic and healing outcomes to better understand the best surgical approach for implant exposure. The trial includes three different surgical procedures. The first is an "I" shaped incision involving careful horizontal and vertical incisions around the implant to expose it and connect a healing abutment without sutures. The second technique, called the Split-Finger Procedure, uses a series of interlacing incisions designed to elevate soft tissue and reconstruct papillae with sutures to secure the tissue. The third method is the Mid-Crestal Sulcular Incision, which involves a long incision along the crest of the gum with flap reflection to access the implant cover screw. Each technique is performed during the implant uncovering phase. Participants will be monitored over several months with assessments including the pink esthetic score at 6 months as the primary outcome. Secondary measures include healing indices at 1 month, volumetric tissue changes at baseline, 3, 6, and 9 months, patient-reported pain using a visual analog scale at 2 weeks, and oral health impact via a questionnaire at 6 months. The study uses double masking and randomized allocation to evaluate outcomes. The total participation involves multiple follow-ups to observe healing and esthetic results after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have received implants in the anterior and premolar regions
  • Implants placed at least 4 months before uncovering in the lower jaw
  • Implants placed at least 6 months before uncovering in the upper jaw
  • Patients with good oral hygiene
  • Medically free patients
  • Adequate keratinized gum tissue
Not Eligible

You will not qualify if you...

  • Acute infection
  • Occlusal trauma
  • Smokers
  • Pregnant or breastfeeding women
  • Severe gag reflex

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo one of three surgical techniques to expose the dental implant during second stage implant surgery.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - 9 months

Participants have follow-up visits to assess healing and esthetic outcomes after surgery.

Visits at 2 weeks, 1 month, 3 months, 6 months, and 9 months (in-person)

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry - The British University in Egypt

Cairo, Egypt

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Research Team

S

Sarah M. Rajab, Bachelor's Degree in Dentistry

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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