Comparative Evaluation of Soft Tissue Healing at Molar and Premolar Socket During Two-Stage Immediate Implant Placement Using Collagen Sponge versus Acellular Dermal Matrix (ADM): A Clinical Trial study

The primary objective of this study is to compare the effects of a collagen sponge and an acellular dermal matrix(ADM)on soft tissue healing outcomes following immediate implant placement

A randomized, single-blinded, parallel-group clinical trial with two intervention groups, on 40 patients. Randomization will be performed using Randomizer.org

Patients requiring tooth extraction and immediate implant placement who present to the Mashhad School of Dentistry during the study period and meet the eligibility criteria will be enrolled in the study. Participants will be randomly assigned to intervention Groups using a block randomization. Outcome assessor and the data analyst will remain unaware of the type of intervention.

Inclusion criteria: adults(18 years older and older) with good general health, good oral hygiene, at least 5mm of bone for primary stability, Indication for molar extraction with immediate implant placement

"Intervention Group 1": After tooth extraction and socket preparation, an immediate implant will be placed in the fresh socket during the same treatment session. The socket entrance will be covered with an absorbable collagen matrix. This material after hydration, will be placed over the socket entrance and fixed with sutures. "Intervention Group 2": After tooth extraction and socket preparation, an immediate implant will be placed in the fresh socket during the same treatment session. The socket entrance will be covered with an Acellular Dermal Matrix (ADM). ADM will be placed over the socket entrance after hydration and fixed with sutures. In both groups, surgery will be performed by a single surgeon, and the surgical protocol, medication regimen, and postoperative care will be identical

Degree of socket epithelialization(percentage)

Participants will be randomly allocated to the two study groups using a permuted block randomization method. The randomization sequence will be generated using Randomization.org. Given that there are two study groups, a block size of four will be used, with the possible allocation sequences being AABB, ABAB, ABBA, BAAB, BABA, and BBAA. An independent researcher who is not involved in patient treatment or outcome assessment will generate and maintain the randomization sequence. To ensure allocation concealment, the assigned group for each participant will be placed in sequentially numbered opaque sealed envelopes (SNOSE). After a participant has been enrolled in the study and immediately before surgery, the corresponding envelope will be provided to the surgeon by the operating room nurse and opened at that time. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent researcher. The envelopes will be opened only after participant enrollment and immediately before surgery. The surgeon will receive the allocation information at the time of intervention.

This study will be conducted using a single-blind design. Due to the nature of the surgical interventions, blinding of the surgeon will not be feasible. Participants will be informed about the treatment they receive as part of the consent process; therefore, patient blinding will not be implemented. However, radiographic evaluators, histomorphometric assessors, and data analysts will remain blinded to group allocation throughout outcome assessment and statistical analysis. Group coding will be performed by an independent researcher who is not involved in treatment delivery or outcome evaluation. Allocation information will be disclosed only after completion of the final statistical analysis

Data related to age, gender, baseline and follow-up photographic images, initial non-epithelialized surface area, involved tooth locations and percentage of epithelialized surface at the recorded time points will be available for sharing. All data will be anonymized and stripped of any personal identifiers to ensure patient confidentiality.

The data access period will begin 6 months after the publication of the study results.

Academic researchers

If other researchers require access to the data, methodology, or analyses used in this study for the purpose of writing articles or theses, the data can be shared while maintaining confidentiality and excluding any patient-identifying information.

The data can be shared upon request via email at msaeid19971376@gmail.com

The data will be provided within a short period after the request is received.