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

Not Applicable

Recruiting

• Conditions: Papilla Reconstruction

• Registration Number: NCT06813846
• Lead Sponsor: British University In Egypt

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-12
• Status Verified: 2024-12
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Submitted: 2025-02-08
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pink Esthetic Score	6 Months	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

Secondary Outcome Measures

Name	Time	Method
Healing Index	1 Month	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).
Volumetric Changes	baseline, 3, 6 and 9 months	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.
Visual analogue scale	2 Weeks	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)
The Oral health impact profile (OHIP-14 questionnaire)	6 Months	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.

Trial Locations

Locations (1)

Faculty of Dentistry - The British University in Egypt; 🇪🇬 Cairo, Egypt